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48 jobs found in california

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    • sunnyvale, california
    • contract
    • $29 - $30 per hour
    job summary: Research Associate l will assist and execute scientific studies performed. This will include performing clinical observations of animals and the essential duties and responsibilities required by the facility. Schedule/Shift: 1st shift, Mon.-Fri. 8:30 a.m.-5:30 p.m.   location: Sunnyvale, California job type: Contract salary: $29 - 30 per hour work hours: 9 to 5 education: Bachelors   responsibilities: Dosing rodents by oral, intraperitoneal, intravenous and intramuscular routes.Performing clinical observations of animals in quarantine and on study.Surgical procedures as well as setting up and taking down for surgery.Necropsy of animals.Collecting data and maintaining accurate and neat study books.Understanding and complying SOPs, GLPs, and other applicable regulations.Some animal husbandry as needed.Performing any other tasks required by the facility, as qualified by training and experience.Working in an efficient and timely manner with minimal supervision.Interacting with clients efficiently and cooperatively.  qualifications: Bachelor's (BS) degree in a scientific field, AALAS certification preferred, or equivalent experience. Concise written and verbal communication skills including knowledge of scientific vernacular necessary. Microsoft Word and Excel skills. Able to work in a fast paced matrix environment. Must be goal oriented and highly self-motivated. Physical Demands Activities may require standing for extended periods Work Environment Work is predominantly performed on company site. Traveling by commercial means or in a personal vehicle may be necessary on rare occasion to accomplish training or business interests.   skills: Clinical research Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance. We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    job summary: Research Associate l will assist and execute scientific studies performed. This will include performing clinical observations of animals and the essential duties and responsibilities required by the facility. Schedule/Shift: 1st shift, Mon.-Fri. 8:30 a.m.-5:30 p.m.   location: Sunnyvale, California job type: Contract salary: $29 - 30 per hour work hours: 9 to 5 education: Bachelors   responsibilities: Dosing rodents by oral, intraperitoneal, intravenous and intramuscular routes.Performing clinical observations of animals in quarantine and on study.Surgical procedures as well as setting up and taking down for surgery.Necropsy of animals.Collecting data and maintaining accurate and neat study books.Understanding and complying SOPs, GLPs, and other applicable regulations.Some animal husbandry as needed.Performing any other tasks required by the facility, as qualified by training and experience.Working in an efficient and timely manner with minimal supervision.Interacting with clients efficiently and cooperatively.  qualifications: Bachelor's (BS) degree in a scientific field, AALAS certification preferred, or equivalent experience. Concise written and verbal communication skills including knowledge of scientific vernacular necessary. Microsoft Word and Excel skills. Able to work in a fast paced matrix environment. Must be goal oriented and highly self-motivated. Physical Demands Activities may require standing for extended periods Work Environment Work is predominantly performed on company site. Traveling by commercial means or in a personal vehicle may be necessary on rare occasion to accomplish training or business interests.   skills: Clinical research Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance. We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    • arcadia, california
    • temp to perm
    • $34 - $38 per hour
    job summary: The Senior Manufacturing Technician, Cell Therapy position is responsible for the hands-on manufacturing of clinical cell therapy product according to current Good Manufacturing Practices (cGMPs) and procedures. The position will work directly with a team of manufacturing technicians, specialists and scientists in Cell Therapy Manufacturing and Process Development.   location: Arcadia, California job type: Temporary salary: $34 - 38 per hour work hours: 9 to 5 education: Bachelors   responsibilities: Participates in the hands-on manufacture of cell therapy products, using state-of-the-art cell manufacturing technologies (i.e., CliniMACS Prodigy, Xuri Bioreactor, M1 Fill and Finish System, etc.), media preparation, cell culture maintenance, sampling and cell counting (i.e., NC200 and CellDrop).Follows and executes batch records and standard operation procedures.Performs aseptic and closed manipulations within Biosafety Cabinet and Grade B, C and D Cleanrooms.Performs manufacturing process steps in accordance with cGMP, procedures and relevant regulations.Performs delegated work assignments in a timely and complete manner.Supports Process Development and Manufacturing Sciences, as needed.Authors and maintains controlled documents including but not limited to SOPs, forms and batch records.Assists with deviation investigations and implementing CAPAs.Assists with qualification and validation activities including equipment qualification, gown qualification, aseptic process validation and process qualification/validation.Maintains manufacturing facility in a 5S and inspection-ready state.Cross trains in other areas including Vector Manufacturing, Manufacturing Sciences, Process Development, QC and QA to perform additional job functions, as necessary.Trains and leads other Technician I on all processes and equipment functionality.Responsible for assisting with startup activities in area of responsibility.Assists in commissioning & qualification of production equipment.Assists in the review & creation of operation documents by providing input to technical composition of documents.Operates on the manufacturing floor in accordance with cGMP's and standard operating procedures.Prepares equipment for manufacturing operations and monitors equipment to ensure process specifications are met.Uses and maintains bench top equipment in accordance with relevant procedures.Effectively demonstrates understanding of cGMPs & applies to specific responsibilities.Follows accurate oral & written procedures when operating production equipment & performing processing steps.Maintains orderliness of process area.Practices safe work habits and adheres to Resilience's safety procedures and guidelines.Assists in training of new and junior staff.Utilizes manufacturing knowledge to improve process operations and affect positive change.Escalates issues related to product and safety to senior staff.  qualifications: Associates/Bachelor's (science preferred) degree with 4+ years in cGMP manufacturing environment or Bachelor's degree and 3+ years experience.  skills: Biology, GMP (Good Manufacturing Practice) Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance. We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    job summary: The Senior Manufacturing Technician, Cell Therapy position is responsible for the hands-on manufacturing of clinical cell therapy product according to current Good Manufacturing Practices (cGMPs) and procedures. The position will work directly with a team of manufacturing technicians, specialists and scientists in Cell Therapy Manufacturing and Process Development.   location: Arcadia, California job type: Temporary salary: $34 - 38 per hour work hours: 9 to 5 education: Bachelors   responsibilities: Participates in the hands-on manufacture of cell therapy products, using state-of-the-art cell manufacturing technologies (i.e., CliniMACS Prodigy, Xuri Bioreactor, M1 Fill and Finish System, etc.), media preparation, cell culture maintenance, sampling and cell counting (i.e., NC200 and CellDrop).Follows and executes batch records and standard operation procedures.Performs aseptic and closed manipulations within Biosafety Cabinet and Grade B, C and D Cleanrooms.Performs manufacturing process steps in accordance with cGMP, procedures and relevant regulations.Performs delegated work assignments in a timely and complete manner.Supports Process Development and Manufacturing Sciences, as needed.Authors and maintains controlled documents including but not limited to SOPs, forms and batch records.Assists with deviation investigations and implementing CAPAs.Assists with qualification and validation activities including equipment qualification, gown qualification, aseptic process validation and process qualification/validation.Maintains manufacturing facility in a 5S and inspection-ready state.Cross trains in other areas including Vector Manufacturing, Manufacturing Sciences, Process Development, QC and QA to perform additional job functions, as necessary.Trains and leads other Technician I on all processes and equipment functionality.Responsible for assisting with startup activities in area of responsibility.Assists in commissioning & qualification of production equipment.Assists in the review & creation of operation documents by providing input to technical composition of documents.Operates on the manufacturing floor in accordance with cGMP's and standard operating procedures.Prepares equipment for manufacturing operations and monitors equipment to ensure process specifications are met.Uses and maintains bench top equipment in accordance with relevant procedures.Effectively demonstrates understanding of cGMPs & applies to specific responsibilities.Follows accurate oral & written procedures when operating production equipment & performing processing steps.Maintains orderliness of process area.Practices safe work habits and adheres to Resilience's safety procedures and guidelines.Assists in training of new and junior staff.Utilizes manufacturing knowledge to improve process operations and affect positive change.Escalates issues related to product and safety to senior staff.  qualifications: Associates/Bachelor's (science preferred) degree with 4+ years in cGMP manufacturing environment or Bachelor's degree and 3+ years experience.  skills: Biology, GMP (Good Manufacturing Practice) Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance. We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    • arcadia, california
    • temp to perm
    • $36 - $42 per hour
    job summary: The QC Microbiology Lab Specialist will assist in the method transfer and validation studies, support commissioning new equipment, support revising and editing Quality system procedures, assist continuous improvement initiatives, and support QC on project teams for clinical and commercial products. Working with QA, manufacturing, and analytical development groups, the QC Microbiology Specialist will be responsible for meeting QC timelines related to deliverables such as method transfer reports, test methods, change controls, and validation protocols and reports.   location: Arcadia, California job type: Temporary salary: $36 - 42 per hour work hours: 9 to 5 education: Bachelors   responsibilities: Assist the transfer and validation of test methods in support of drug substance release and stability testing.Revise test methods, validation protocols and reports, Quality system SOPs, and other supporting documents.Support equipment onboarding and validation lifecycle, including operation and maintenance procedures and software systems.Assist initiating change controls, support investigations, CAPAs, and continuous improvement initiatives to successful completion.Represent QC Microbiology on project teams for clinical and commercial products with primary responsibility for validation of Drug Substance release assays.Support performing validation of microbiological assays and assist provide training related to in-process and drug substance testing, equipment, environmental and utility monitoring to include Bioburden, Endotoxin, Growth Promotion testing, etc.Assist and support to perform environmental and utility monitoring of the cell and gene therapy production facility according to written procedures while fully gowned including operational monitoring and personnel monitoring during aseptic processing, and aseptic filling. Assist and support to perform routine environmental monitoring, as needed to meet schedules.Read environmental and utility monitoring plates by counting microbial colonies. Fill out appropriate reports and forms contemporaneously. Assist to perform microbial identification like gram stains, gene sequencing. Track all data and complete in a timely manner. Perform all activities in compliance with cGMP regulations.Assist preparation and presentation of quarterly and annual reports, trend investigations, statements of quality, and other applicable reports to management.Support onboarding and qualification of laboratory equipment and GMP software systems.Generate and write SOPs and protocols related to test methods involving product lot release.Draft technical documents including test methods, validation documents, and deviations.Assist implementation of change controls, support investigations, and complete CAPAs in support of GMP operations.Assist in purchasing all necessary supplies, needed for QC Microbiology. Assist to receive supplies, log-in and store appropriately following written procedures. Assist to perform growth promotion analyses on all microbiological media lots received. Report results on appropriate forms.Inspect and clean the laboratory and its equipment on a regular basis. Perform laboratory and equipment cleaning, preventative maintenance and calibration as described in written procedures. Follow written procedures for cleaning. Record all necessary information and maintain current, accurate, legible records of all work performed. Report problems to management in a timely manner and support finding creative solutions to resolve them.Ensure compliance to all quality requirements to meet audit standards and regulatory compliance.Maintain lab equipment, reagents inventory, and documentation to ensure accurate, timely, and cost-effective analysis of materials and products.Assist creating training materials and training staff on methods and related SOPs.Support implementation and qualification of current and new pharmacopoeia methods to ensure compliance with cGMP's and other regulatory requirements.Assist analyzing and summarizing data into reports and certificates of analysis with attention to details.Participate in risk assessments such as HAZOP's and FMEA's.Assist proposing corrective and preventive actions and improvements identified through investigations and audits and assist performing effectiveness checks of CAPA's.Perform sample management tasks, including labeling, shipping to external labs, inventory, and disposal of samples.Participate in collaboration meetings with external clients, contractors, and vendors.Participate in internal audits and external audits and support providing responses and implementation of actions related to observations.Other duties as assigned by management.  qualifications: Bachelor's degree in Microbiology, Molecular and Cell biology, Biology or related field required. In lieu of this requirement, work experience may be consideredMinimum of 5 years of work experience in the Pharmaceutical, Life Sciences industry with cGMP, GLPA strong background in method development, qualification and validation is highly desired. A background in quality control testing related to Biopharmaceuticals is required.Experience with problem solving methods such as DMAIC or other similar Root Cause Analysis ToolsStrong knowledge of cGMP and ICH guidelines. Other regulatory agencies experiences preferredBasic knowledge of Compendial (i.e., USP, EP, JP, etc.) requirements and standardsExperience with electronic Laboratory Information Management Systems (LIMS)Strong understanding of Microbiology related to drug substance or drug product manufacturing.Experience with relevant microbiology laboratory equipment and software  skills: Cell Biology, CAPA, Biology, GLP (Good Laboratory Practice), ICH Regulations, GMP (Good Manufacturing Practice) Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance. We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    job summary: The QC Microbiology Lab Specialist will assist in the method transfer and validation studies, support commissioning new equipment, support revising and editing Quality system procedures, assist continuous improvement initiatives, and support QC on project teams for clinical and commercial products. Working with QA, manufacturing, and analytical development groups, the QC Microbiology Specialist will be responsible for meeting QC timelines related to deliverables such as method transfer reports, test methods, change controls, and validation protocols and reports.   location: Arcadia, California job type: Temporary salary: $36 - 42 per hour work hours: 9 to 5 education: Bachelors   responsibilities: Assist the transfer and validation of test methods in support of drug substance release and stability testing.Revise test methods, validation protocols and reports, Quality system SOPs, and other supporting documents.Support equipment onboarding and validation lifecycle, including operation and maintenance procedures and software systems.Assist initiating change controls, support investigations, CAPAs, and continuous improvement initiatives to successful completion.Represent QC Microbiology on project teams for clinical and commercial products with primary responsibility for validation of Drug Substance release assays.Support performing validation of microbiological assays and assist provide training related to in-process and drug substance testing, equipment, environmental and utility monitoring to include Bioburden, Endotoxin, Growth Promotion testing, etc.Assist and support to perform environmental and utility monitoring of the cell and gene therapy production facility according to written procedures while fully gowned including operational monitoring and personnel monitoring during aseptic processing, and aseptic filling. Assist and support to perform routine environmental monitoring, as needed to meet schedules.Read environmental and utility monitoring plates by counting microbial colonies. Fill out appropriate reports and forms contemporaneously. Assist to perform microbial identification like gram stains, gene sequencing. Track all data and complete in a timely manner. Perform all activities in compliance with cGMP regulations.Assist preparation and presentation of quarterly and annual reports, trend investigations, statements of quality, and other applicable reports to management.Support onboarding and qualification of laboratory equipment and GMP software systems.Generate and write SOPs and protocols related to test methods involving product lot release.Draft technical documents including test methods, validation documents, and deviations.Assist implementation of change controls, support investigations, and complete CAPAs in support of GMP operations.Assist in purchasing all necessary supplies, needed for QC Microbiology. Assist to receive supplies, log-in and store appropriately following written procedures. Assist to perform growth promotion analyses on all microbiological media lots received. Report results on appropriate forms.Inspect and clean the laboratory and its equipment on a regular basis. Perform laboratory and equipment cleaning, preventative maintenance and calibration as described in written procedures. Follow written procedures for cleaning. Record all necessary information and maintain current, accurate, legible records of all work performed. Report problems to management in a timely manner and support finding creative solutions to resolve them.Ensure compliance to all quality requirements to meet audit standards and regulatory compliance.Maintain lab equipment, reagents inventory, and documentation to ensure accurate, timely, and cost-effective analysis of materials and products.Assist creating training materials and training staff on methods and related SOPs.Support implementation and qualification of current and new pharmacopoeia methods to ensure compliance with cGMP's and other regulatory requirements.Assist analyzing and summarizing data into reports and certificates of analysis with attention to details.Participate in risk assessments such as HAZOP's and FMEA's.Assist proposing corrective and preventive actions and improvements identified through investigations and audits and assist performing effectiveness checks of CAPA's.Perform sample management tasks, including labeling, shipping to external labs, inventory, and disposal of samples.Participate in collaboration meetings with external clients, contractors, and vendors.Participate in internal audits and external audits and support providing responses and implementation of actions related to observations.Other duties as assigned by management.  qualifications: Bachelor's degree in Microbiology, Molecular and Cell biology, Biology or related field required. In lieu of this requirement, work experience may be consideredMinimum of 5 years of work experience in the Pharmaceutical, Life Sciences industry with cGMP, GLPA strong background in method development, qualification and validation is highly desired. A background in quality control testing related to Biopharmaceuticals is required.Experience with problem solving methods such as DMAIC or other similar Root Cause Analysis ToolsStrong knowledge of cGMP and ICH guidelines. Other regulatory agencies experiences preferredBasic knowledge of Compendial (i.e., USP, EP, JP, etc.) requirements and standardsExperience with electronic Laboratory Information Management Systems (LIMS)Strong understanding of Microbiology related to drug substance or drug product manufacturing.Experience with relevant microbiology laboratory equipment and software  skills: Cell Biology, CAPA, Biology, GLP (Good Laboratory Practice), ICH Regulations, GMP (Good Manufacturing Practice) Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance. We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    • arcadia, california
    • temp to perm
    • $33 - $39 per hour
    job summary: The QC Analytical Lab Specialist/Sr. Specialist has a unique opportunity to play a key role in building of the QC laboratory from ground up for a Cell and Gene therapy biotech startup. The QC Analytical Lab Specialist will be responsible for leading and managing activities for method transfer, qualification, and validation of client methods. The role is responsible for execution of testing for cGMP samples for in-process, lot release and stability samples in-house. The role will support and coordinate the biochemical, cell based, molecular biology and general chemical testing of raw material, in-process, final product, and stability samples submitted to external laboratories. This role will be responsible for documentation that is compliant with all applicable procedures, standards, and cGMP regulations.   location: Arcadia, California job type: Temporary salary: $33 - 39 per hour work hours: 9 to 5 education: Bachelors   responsibilities: Leads implementation of new methods transferred by the clients and Analytical Development lab.Originates and revises QC related procedures and analytical methods.Leads and supports invalid assay, exceptions, and lab investigations.Ensures compliance to all quality requirements to meet audit standards and regulatory compliance.Maintains lab equipment, reagents inventory, and documentation to ensure accurate, timely, and costeffective analysis of materials and products.Assists in creating training materials and trains staff on methods and related SOPsCollaborates with other Functional Areas (Analytical Development, Materials Sciences and Technology, Process Development and Manufacturing) for methods transfer, qualifications, validation, sample plan development and timely testing of samples.Executes assays to assess various cell and gene therapy products using flow cytometer, PCR, and cell-based assays.Performs and troubleshoots on laboratory methods and procedures including ddPCR, qPCR, ELISA, and flow cytometry. - Implements, and qualifies current and new pharmacopoeia methods to ensure compliance with cGMP's and other regulatory requirements.Analyzes and summarizes data into reports and certificate of analysis with attention to details.Participates in risk assessment, HAZOP and FMEA.Reviews and proposes corrective and preventive actions and improvements identified through investigations and audits.Performs sample management tasks, including labeling, shipping to external labs, inventory, and disposal of samples.Collaborates with external clients, contractors, and vendors.Participates with internal audits and external audits and assists in authoring responses and implementation of actions.Other duties as assigned by management.  qualifications: Bachelor's degree in Biochemistry, Chemistry, Molecular and Cell biology, or Biology required. Masters degree preferred. In lieu of this requirement, work experience may be consideredMinimum of 5 years of work experience in the Pharmaceutical, Life Sciences industry with cGMP, GLPExperience with problem solving methods such as DMAIC or other similar Root Cause Analysis ToolsStrong knowledge of cGMP and ICH guidelines. Other regulatory agencies experiences preferredBasic knowledge of Compendial (i.e., USP, EP, JP, etc.) requirements and standardsExperience with electronic Laboratory Inventory Management Systems (LIMS)  skills: Cell Biology, Biology, GLP (Good Laboratory Practice), ICH Regulations, GMP (Good Manufacturing Practice) Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance. We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    job summary: The QC Analytical Lab Specialist/Sr. Specialist has a unique opportunity to play a key role in building of the QC laboratory from ground up for a Cell and Gene therapy biotech startup. The QC Analytical Lab Specialist will be responsible for leading and managing activities for method transfer, qualification, and validation of client methods. The role is responsible for execution of testing for cGMP samples for in-process, lot release and stability samples in-house. The role will support and coordinate the biochemical, cell based, molecular biology and general chemical testing of raw material, in-process, final product, and stability samples submitted to external laboratories. This role will be responsible for documentation that is compliant with all applicable procedures, standards, and cGMP regulations.   location: Arcadia, California job type: Temporary salary: $33 - 39 per hour work hours: 9 to 5 education: Bachelors   responsibilities: Leads implementation of new methods transferred by the clients and Analytical Development lab.Originates and revises QC related procedures and analytical methods.Leads and supports invalid assay, exceptions, and lab investigations.Ensures compliance to all quality requirements to meet audit standards and regulatory compliance.Maintains lab equipment, reagents inventory, and documentation to ensure accurate, timely, and costeffective analysis of materials and products.Assists in creating training materials and trains staff on methods and related SOPsCollaborates with other Functional Areas (Analytical Development, Materials Sciences and Technology, Process Development and Manufacturing) for methods transfer, qualifications, validation, sample plan development and timely testing of samples.Executes assays to assess various cell and gene therapy products using flow cytometer, PCR, and cell-based assays.Performs and troubleshoots on laboratory methods and procedures including ddPCR, qPCR, ELISA, and flow cytometry. - Implements, and qualifies current and new pharmacopoeia methods to ensure compliance with cGMP's and other regulatory requirements.Analyzes and summarizes data into reports and certificate of analysis with attention to details.Participates in risk assessment, HAZOP and FMEA.Reviews and proposes corrective and preventive actions and improvements identified through investigations and audits.Performs sample management tasks, including labeling, shipping to external labs, inventory, and disposal of samples.Collaborates with external clients, contractors, and vendors.Participates with internal audits and external audits and assists in authoring responses and implementation of actions.Other duties as assigned by management.  qualifications: Bachelor's degree in Biochemistry, Chemistry, Molecular and Cell biology, or Biology required. Masters degree preferred. In lieu of this requirement, work experience may be consideredMinimum of 5 years of work experience in the Pharmaceutical, Life Sciences industry with cGMP, GLPExperience with problem solving methods such as DMAIC or other similar Root Cause Analysis ToolsStrong knowledge of cGMP and ICH guidelines. Other regulatory agencies experiences preferredBasic knowledge of Compendial (i.e., USP, EP, JP, etc.) requirements and standardsExperience with electronic Laboratory Inventory Management Systems (LIMS)  skills: Cell Biology, Biology, GLP (Good Laboratory Practice), ICH Regulations, GMP (Good Manufacturing Practice) Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance. We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    • arcadia, california
    • permanent
    • $100,000 - $130,000 per year
    job summary: This role will focus on the Discovery of Antibody based biologics and T/NK cell products as well as assist with planning and execution of experiments, in support of developing analytical methods for releasing and characterizing T cell therapy products. Candidates with strong expertise in phage display library construction and antibody engineering will be given preference.   location: Arcadia, California job type: Permanent salary: $100,000 - 130,000 per year work hours: 9 to 5 education: Masters   responsibilities: Use expertise in molecular biology to generate Chimeric Antigen Receptor (CAR) or antibody constructs.Engineer lentiviral vectors with insertion or deletion of restriction sites, epitope tags or other genetic elements.Generate viral vectors expressing scFv or CAR variants, site directed mutants, and fusion proteins using fusion PCR and Gibson or other fragment assembly methods.Design and clone shRNA, gRNA for desired targets in CRISPR/Cas9 vectors.Design strategies to knock-in CAR in T cellsPerform antibody phage display screens and validation of clones by ELISA and flow cytometry.Express/Purify antibodies and recombinant proteins in bacteria or mammalian cells.Develop biochemical, cell based and immunoassays to evaluate antibody binding affinitiesOptimize qPCR/ddPCR assays to characterize viral and CAR-T products.Construct phage display librariesPerform restriction analysis, ligation, transformation, colony PCR screens and gel electrophoresis.Develop generate stable cell lines with overexpression or knock out (CRISPR shRNA).Prepare plasmids in small scale and large scale, maintain plasmid and bacterial glycerol stocks.Maintain cell lines, prepare cell banks (adherent and suspension cell lines) as required.Perform cytokine ELISAs and Western blotting.Perform cell-based (proliferation, cytotoxicity, transcription factor reporter) assays in multi well formats, analyze and clearly document data.Perform experiments with minimal supervision, think critically and demonstrate troubleshooting and problem-solving skills.Self-motivated, pays attention to details, and willing to accept responsibilities outside of the initial job descriptionDevelop precise SOPs complying with GLP environment and maintain excellent records that allow systematic tracking and protocol transfer.Basic proficiency in various software (Excel, PowerPoint, Graph Pad Prism, Photoshop and Plasmid design/analysis software)  qualifications: MS Degree preferably with at least 5+ years of laboratory experience or PhD with 2+ years of laboratory experience in the field of Immunology, cell biology, virology, or molecular biology.Experience in phage display library construction, antibody engineering, humanization or affinity maturation of antibodies are preferred.Strong technical skills in advanced molecular cloning and fragment assembly techniques are requiredStrong experience in cell based and biochemical assays are required - must be able to perform assays in 96 and 384 well formats with different formats without confusion.Experience in working with multiple cell lines (both suspension and adherent) and setting up cell-based assays.General lab experience in operating and maintaining basic lab equipment (centrifuge, microscope, PCR machines, nanodrop, DNA and protein electrophoresis systems).Hands on experience with sterile microbiology and molecular biology techniques not limited to cloning, mutagenesis, restriction digestion, ligation, transformation, colony PCR, culturing bacterial cells, plasmid preparations.Critical to have the ability to maintain accurate records and back track samples prepared without confusion.Prior experience in optimizing and trouble-shooting qPCR and ddPCRCommunicate ideas and results clearly and effectively (both verbally and in writing) to the team members.Must feel comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing prioritiesAbility to adapt to startup environment and make the best use of the existing resources to helping the team to move towards perfectionFamiliarity with routine lab operations and safety procedures.  skills: Biology, Chemistry, GLP (Good Laboratory Practice), ICH Regulations, GMP (Good Manufacturing Practice) Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.EOEDisclaime For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    job summary: This role will focus on the Discovery of Antibody based biologics and T/NK cell products as well as assist with planning and execution of experiments, in support of developing analytical methods for releasing and characterizing T cell therapy products. Candidates with strong expertise in phage display library construction and antibody engineering will be given preference.   location: Arcadia, California job type: Permanent salary: $100,000 - 130,000 per year work hours: 9 to 5 education: Masters   responsibilities: Use expertise in molecular biology to generate Chimeric Antigen Receptor (CAR) or antibody constructs.Engineer lentiviral vectors with insertion or deletion of restriction sites, epitope tags or other genetic elements.Generate viral vectors expressing scFv or CAR variants, site directed mutants, and fusion proteins using fusion PCR and Gibson or other fragment assembly methods.Design and clone shRNA, gRNA for desired targets in CRISPR/Cas9 vectors.Design strategies to knock-in CAR in T cellsPerform antibody phage display screens and validation of clones by ELISA and flow cytometry.Express/Purify antibodies and recombinant proteins in bacteria or mammalian cells.Develop biochemical, cell based and immunoassays to evaluate antibody binding affinitiesOptimize qPCR/ddPCR assays to characterize viral and CAR-T products.Construct phage display librariesPerform restriction analysis, ligation, transformation, colony PCR screens and gel electrophoresis.Develop generate stable cell lines with overexpression or knock out (CRISPR shRNA).Prepare plasmids in small scale and large scale, maintain plasmid and bacterial glycerol stocks.Maintain cell lines, prepare cell banks (adherent and suspension cell lines) as required.Perform cytokine ELISAs and Western blotting.Perform cell-based (proliferation, cytotoxicity, transcription factor reporter) assays in multi well formats, analyze and clearly document data.Perform experiments with minimal supervision, think critically and demonstrate troubleshooting and problem-solving skills.Self-motivated, pays attention to details, and willing to accept responsibilities outside of the initial job descriptionDevelop precise SOPs complying with GLP environment and maintain excellent records that allow systematic tracking and protocol transfer.Basic proficiency in various software (Excel, PowerPoint, Graph Pad Prism, Photoshop and Plasmid design/analysis software)  qualifications: MS Degree preferably with at least 5+ years of laboratory experience or PhD with 2+ years of laboratory experience in the field of Immunology, cell biology, virology, or molecular biology.Experience in phage display library construction, antibody engineering, humanization or affinity maturation of antibodies are preferred.Strong technical skills in advanced molecular cloning and fragment assembly techniques are requiredStrong experience in cell based and biochemical assays are required - must be able to perform assays in 96 and 384 well formats with different formats without confusion.Experience in working with multiple cell lines (both suspension and adherent) and setting up cell-based assays.General lab experience in operating and maintaining basic lab equipment (centrifuge, microscope, PCR machines, nanodrop, DNA and protein electrophoresis systems).Hands on experience with sterile microbiology and molecular biology techniques not limited to cloning, mutagenesis, restriction digestion, ligation, transformation, colony PCR, culturing bacterial cells, plasmid preparations.Critical to have the ability to maintain accurate records and back track samples prepared without confusion.Prior experience in optimizing and trouble-shooting qPCR and ddPCRCommunicate ideas and results clearly and effectively (both verbally and in writing) to the team members.Must feel comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing prioritiesAbility to adapt to startup environment and make the best use of the existing resources to helping the team to move towards perfectionFamiliarity with routine lab operations and safety procedures.  skills: Biology, Chemistry, GLP (Good Laboratory Practice), ICH Regulations, GMP (Good Manufacturing Practice) Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.EOEDisclaime For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    • arcadia, california
    • permanent
    • $100,000 - $130,000 per year
    job summary: This role will independently design and execute experiments, mentor technical staff, collaborate with other cross functional teams to support research projects under the supervision of R & D director. Passion for excellence and innovation are critical. This role will work closely with our internal colleagues and external collaborators to efficiently progress early-stage cell therapy products through to IND filing.   location: Arcadia, California job type: Permanent salary: $100,000 - 130,000 per year work hours: 9 to 5 education: Doctorate   responsibilities: Lead planning, design, and execution of experiments related of development and characterization of cellular immunotherapy products in coordination with R & D Director.Analyze, and report complex data to cross functional teams in a clear and concise mannerMentor and train scientific staff on technical skills required to effectively perform experiments and to facilitate progression of projectsManage multiple research projects simultaneously with the R & D team and collaborate with other departments (Process Science, Analytical Science, Quality, Manufacture) as necessary.Contribute to various preclinical projects within R& D and those required by clients through in-depth scientific knowledge and demonstrated experience in analytical methods used in cellular immunotherapy fieldCollaborate with Process science team to scale up lentiviral and CAR-T productsPerforms a wide range of non-routine exploratory experiments as requiredMaintain precise laboratory notebooks, electronic records following high standards of data quality and integrity.Prepare scientific/technical reports, summaries, protocols, etc, and present them to internal and external stakeholders.Constantly improvise research strategies and adopt technologies to stay upfront in the field of immunotherapy  qualifications: Ph. D in the field of Immunology, Cell biology, Virology or Cancer biology or related life science discipline with 3+ years (Scientist) or 5+ years (Senior Scientist) or Master's degree with 7 + years relevant research experience in Immunology/Cancer biology.In depth scientific and technical understanding of cellular immunotherapy and tumor immunology.2+ years of managing research laboratory research team/associates in immunotherapy or cancer biology or relevant research projects is required for senior scientist level.Prior research experience in antibody therapies, bispecific antibodies, and cellular therapies preferredDemonstrated ability to independently design, plan and troubleshoot experiments, interpret results, and present to the R&D team and external clients.Self-motivated and creative, able to work within a team and collaborate with external teams as needed to accomplish project objectives and deliverables.Possess ability to identify problems early, technically trouble shoot and resolve challenges in early development and preclinical validation of CAR-T productsUnderstands the importance of data integrity to enable a smooth transition of discovery research to manufacture and clinical trials.Familiarity with FDA regulation of biologics and cell therapy products, IND-filing, GLP/GMP process is a plus.Ability to stay organized, prioritize tasks, manage time efficiently, and provide creative solutions to meet program needsExcellent interpersonal, verbal, and written communication skillsComfortable working in a fast-paced startup environment and flexible to adjust workload based upon changing prioritiesA strong academic research experience evidenced by high caliber publications in peer-reviewed journals is preferredIntellectually curios candidates with passion for innovation and discovery research are welcome  skills: Biology, Chemistry, GLP (Good Laboratory Practice), ICH Regulations, GMP (Good Manufacturing Practice) Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.EOEDisclaime For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    job summary: This role will independently design and execute experiments, mentor technical staff, collaborate with other cross functional teams to support research projects under the supervision of R & D director. Passion for excellence and innovation are critical. This role will work closely with our internal colleagues and external collaborators to efficiently progress early-stage cell therapy products through to IND filing.   location: Arcadia, California job type: Permanent salary: $100,000 - 130,000 per year work hours: 9 to 5 education: Doctorate   responsibilities: Lead planning, design, and execution of experiments related of development and characterization of cellular immunotherapy products in coordination with R & D Director.Analyze, and report complex data to cross functional teams in a clear and concise mannerMentor and train scientific staff on technical skills required to effectively perform experiments and to facilitate progression of projectsManage multiple research projects simultaneously with the R & D team and collaborate with other departments (Process Science, Analytical Science, Quality, Manufacture) as necessary.Contribute to various preclinical projects within R& D and those required by clients through in-depth scientific knowledge and demonstrated experience in analytical methods used in cellular immunotherapy fieldCollaborate with Process science team to scale up lentiviral and CAR-T productsPerforms a wide range of non-routine exploratory experiments as requiredMaintain precise laboratory notebooks, electronic records following high standards of data quality and integrity.Prepare scientific/technical reports, summaries, protocols, etc, and present them to internal and external stakeholders.Constantly improvise research strategies and adopt technologies to stay upfront in the field of immunotherapy  qualifications: Ph. D in the field of Immunology, Cell biology, Virology or Cancer biology or related life science discipline with 3+ years (Scientist) or 5+ years (Senior Scientist) or Master's degree with 7 + years relevant research experience in Immunology/Cancer biology.In depth scientific and technical understanding of cellular immunotherapy and tumor immunology.2+ years of managing research laboratory research team/associates in immunotherapy or cancer biology or relevant research projects is required for senior scientist level.Prior research experience in antibody therapies, bispecific antibodies, and cellular therapies preferredDemonstrated ability to independently design, plan and troubleshoot experiments, interpret results, and present to the R&D team and external clients.Self-motivated and creative, able to work within a team and collaborate with external teams as needed to accomplish project objectives and deliverables.Possess ability to identify problems early, technically trouble shoot and resolve challenges in early development and preclinical validation of CAR-T productsUnderstands the importance of data integrity to enable a smooth transition of discovery research to manufacture and clinical trials.Familiarity with FDA regulation of biologics and cell therapy products, IND-filing, GLP/GMP process is a plus.Ability to stay organized, prioritize tasks, manage time efficiently, and provide creative solutions to meet program needsExcellent interpersonal, verbal, and written communication skillsComfortable working in a fast-paced startup environment and flexible to adjust workload based upon changing prioritiesA strong academic research experience evidenced by high caliber publications in peer-reviewed journals is preferredIntellectually curios candidates with passion for innovation and discovery research are welcome  skills: Biology, Chemistry, GLP (Good Laboratory Practice), ICH Regulations, GMP (Good Manufacturing Practice) Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.EOEDisclaime For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    • berkeley, california
    • contract
    • $22.73 - $26.74 per hour
    job summary: DEPARTMENT/TEAM DESCRIPTION Quality Control (QC) department, Chemistry group that performs testing on drug substance and drug products. Testing is HPLC / HIAC / ICP-based. POSITION SUMMARY Contract position is available to support QC Chemistry I group for release testing, method transfers to other equipment, equipment transfers from ESE to B88. Contractor will support testing, documentation, and general lab duties. This role requires employees to be fully vaccinated against COVID-19 as a condition of employment, subject to a valid medical or religious accommodation.   location: Berkeley, California job type: Contract salary: $22.73 - 26.74 per hour work hours: 8 to 4 education: Bachelors   responsibilities: Perform analytical testing to support the release, stability, and in process testing samples, or final products;Follow, accurately, relevant standard operating procedures (SOPs), perform all activities in accordance with certified good manufacturing practice (cGMP) requirements reports abnormalitiesInitiate and complete laboratory discrepancy events on timeKeep accurate documentation and track recordCompile, enter and review data into LIMS or other databases/Excel sheetsConfirm documents test results to ensure completeness and accuracy per cGMPs  qualifications: Bachelor's degree (BS) in a scientific discipline Skill & Competency Requirements: Experience with a cGMPExperience with chromatography systemsAbility to multi-task and good adaptabilityFocus on GoalsIntegrity and Commitment to Company Beliefs and Values Preferences: Experience with Wet-Chemical techniquesExperience with Chromatography  skills: Chemistry, Chromatography, GMP (Good Manufacturing Practice) Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance. We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    job summary: DEPARTMENT/TEAM DESCRIPTION Quality Control (QC) department, Chemistry group that performs testing on drug substance and drug products. Testing is HPLC / HIAC / ICP-based. POSITION SUMMARY Contract position is available to support QC Chemistry I group for release testing, method transfers to other equipment, equipment transfers from ESE to B88. Contractor will support testing, documentation, and general lab duties. This role requires employees to be fully vaccinated against COVID-19 as a condition of employment, subject to a valid medical or religious accommodation.   location: Berkeley, California job type: Contract salary: $22.73 - 26.74 per hour work hours: 8 to 4 education: Bachelors   responsibilities: Perform analytical testing to support the release, stability, and in process testing samples, or final products;Follow, accurately, relevant standard operating procedures (SOPs), perform all activities in accordance with certified good manufacturing practice (cGMP) requirements reports abnormalitiesInitiate and complete laboratory discrepancy events on timeKeep accurate documentation and track recordCompile, enter and review data into LIMS or other databases/Excel sheetsConfirm documents test results to ensure completeness and accuracy per cGMPs  qualifications: Bachelor's degree (BS) in a scientific discipline Skill & Competency Requirements: Experience with a cGMPExperience with chromatography systemsAbility to multi-task and good adaptabilityFocus on GoalsIntegrity and Commitment to Company Beliefs and Values Preferences: Experience with Wet-Chemical techniquesExperience with Chromatography  skills: Chemistry, Chromatography, GMP (Good Manufacturing Practice) Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance. We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    • berkeley, california
    • contract
    • $20.90 - $24.59 per hour
    job summary: Job Summary Support in the manufacture of company products by performing daily purification operations in accordance to cGMP and safety regulations to minimize any loss of sales. This role requires employees to be fully vaccinated against COVID-19 as a condition of employment, subject to a valid medical or religious accommodation. Schedule/Shift: 1st shift, Mon.-Fri. 8:00am-5:00pm   location: Berkeley, California job type: Contract salary: $20.90 - 24.59 per hour work hours: 9 to 5 education: Associate   responsibilities: Job Responsibilities Prepares process equipment (including but not limited to ancillary equipment, Stainless Steel tanks, Pressure Transmitters, Flow Meters, Transfer lines (buffers), Hoses and small parts.Cleans and Sterilizes equipment using appropriate CIP (Clean-In- Place), SIP (Steam-In-Place) procedures.Performs daily or routine process operations in the purification of biotech and biological products.Operates equipment for these processes including:Operates 50L, 200L and 1000L collection bag technology to ensure robust collection, mixing and dilution of products. Operates automated bagging systems.Blast Freezes product for storage.Dispenses chemicals and formulate solutions.Prepares acids and bases as necessary. Performs aseptic operations.Monitors and controls operation with computer control systems.Completes all routine check sheets.Cleans equipment and maintains clean and orderly production facilities.Performs all operations in compliance with cGMP.Performs other related duties as assigned.  qualifications: Requires completion of two-years' college science courses in (e.g. biology, chemistry, biochemistry, or microbiology) or a certificate from an accredited bio-technology academy.Relevant bio-tech industry experience in some or all of the following is preferred, and may be considered in lieu of some or all of the educational requirements above. Basic knowledge of protein chemistry and purification systems such as anion, cation, and immunoaffinity chromatography.Familiarity with cGMP's and applicable agency regulations. Preferences: Read, write, speak, and comprehend English in order to understand written and verbal instructions, SOP's, BPR's, etc.Good verbal and written communication skills.Work weekends, holidays and overtime as required.Acceptable attendance and performance.Able to work both independently/self-directed with minimal supervision and in a team environment.Detail oriented with the ability to demonstrate good record keeping practices and ability to follow data integrity rules.Computer skills required. Including: ability to learn software applications such as the learning management system (LMS), document control, e-mail (Outlook)Must be able to cope with fast paced operations and repeatedly perform multi-step simultaneous operations with high degree of accuracy.  skills: Chemistry, GMP (Good Manufacturing Practice) Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance. We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    job summary: Job Summary Support in the manufacture of company products by performing daily purification operations in accordance to cGMP and safety regulations to minimize any loss of sales. This role requires employees to be fully vaccinated against COVID-19 as a condition of employment, subject to a valid medical or religious accommodation. Schedule/Shift: 1st shift, Mon.-Fri. 8:00am-5:00pm   location: Berkeley, California job type: Contract salary: $20.90 - 24.59 per hour work hours: 9 to 5 education: Associate   responsibilities: Job Responsibilities Prepares process equipment (including but not limited to ancillary equipment, Stainless Steel tanks, Pressure Transmitters, Flow Meters, Transfer lines (buffers), Hoses and small parts.Cleans and Sterilizes equipment using appropriate CIP (Clean-In- Place), SIP (Steam-In-Place) procedures.Performs daily or routine process operations in the purification of biotech and biological products.Operates equipment for these processes including:Operates 50L, 200L and 1000L collection bag technology to ensure robust collection, mixing and dilution of products. Operates automated bagging systems.Blast Freezes product for storage.Dispenses chemicals and formulate solutions.Prepares acids and bases as necessary. Performs aseptic operations.Monitors and controls operation with computer control systems.Completes all routine check sheets.Cleans equipment and maintains clean and orderly production facilities.Performs all operations in compliance with cGMP.Performs other related duties as assigned.  qualifications: Requires completion of two-years' college science courses in (e.g. biology, chemistry, biochemistry, or microbiology) or a certificate from an accredited bio-technology academy.Relevant bio-tech industry experience in some or all of the following is preferred, and may be considered in lieu of some or all of the educational requirements above. Basic knowledge of protein chemistry and purification systems such as anion, cation, and immunoaffinity chromatography.Familiarity with cGMP's and applicable agency regulations. Preferences: Read, write, speak, and comprehend English in order to understand written and verbal instructions, SOP's, BPR's, etc.Good verbal and written communication skills.Work weekends, holidays and overtime as required.Acceptable attendance and performance.Able to work both independently/self-directed with minimal supervision and in a team environment.Detail oriented with the ability to demonstrate good record keeping practices and ability to follow data integrity rules.Computer skills required. Including: ability to learn software applications such as the learning management system (LMS), document control, e-mail (Outlook)Must be able to cope with fast paced operations and repeatedly perform multi-step simultaneous operations with high degree of accuracy.  skills: Chemistry, GMP (Good Manufacturing Practice) Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance. We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    • arcadia, california
    • permanent
    • $130,000 - $150,000 per year
    job summary: This role will lead a multi-functional laboratory team developing analytical (molecular, bioassays, and immuno-assays inclusive) assays to support the development of novel modified autologous and allogeneic cell/gene therapies. The role will also be responsible for preclinical and clinical assay development/ optimization/ qualification to support required testing of cell/gene therapies and viral vectors used in the manufacturing process.   location: Arcadia, California job type: Permanent salary: $130,000 - 150,000 per year work hours: 9 to 5 education: Masters   responsibilities: Expert in analytical assay development adopting the quality-by-design concept to support testing of all pre-clinical and clinical Theragent cell therapy programs.Provide strategic and scientific guidance in all analytical development technical areas; Serve as the analytical development expert on molecular/ biological/ immuno-assays, structure-function relationships, test method development and qualification/ validation, and establishment of specifications, including cell and gene therapy programs.Oversee all analytical development personnel and activities, including laboratory. equipment/instrumentation, execution of testing, and data interpretation of results.Develop method platforms to support current and new product formats, increased product control, lower cost, and lower operational laboratory complexity.Work strategically to accelerate the development and implementation of novel testing technologies for integration into new and existing drug products.Play a key role in project team meetings and decisions working closely with other functions such as Research, Regulatory Affairs, Manufacturing, Quality, Clinical, Finance, Program Management, Business Development, and others.Prepare and present to leadership, external clients, and stakeholders on analytical method development strategy, latest data and conclusions, plans and roadmap to meet client and Theragent testing development goals.Responsible for method LCM; execute on IND development timelines against operational plans.Builds a strong scientific and technical laboratory team, provides necessary training and ongoing coaching, discipline, and recognition of direct staff, including performing annual performance reviews.Support technology transfer of products and processes into the cGMP facility, and serve as a key SME with external laboratory organizations and key clients as well as material/component and equipment/instrument vendors.Investigate and resolve problems, identify root cause, and propose laboratory operation improvements through clear communication to senior management.Interact with outside vendors and senior management.Participate in multi-functional project teams, as necessary.Take corrective action to bring about required changes using approved change control procedures.  qualifications: Masters/Ph. D degree in Biochemistry, Cell Biology, Molecular Biology, Virology, Biological Sciences with 5 - 8 years of experience managing a technical laboratory team in the cell therapy biotechnology industry.Direct experience with cell and gene therapy process development, IND filing, and supporting clinical products expectations is required.In-depth experience and knowledge in biotherapeutics analytics with emphasis on cell-based potency methods, cellular characterization, viral characterization and infectivity assays, molecular methods, antigenicity methods, and other separation-based methods used for gene/cell therapies.Two to three years managing an analytical science or multi-functional bioanalytical laboratory technical team.Familiar with the FDA regulatory requirements for drug products and IND filingKnowledgeable of cGMP processes and technology transfer.Demonstrated ability to design and execute laboratory experiments and evaluate data to provide scientific guidance on assay optimization.Demonstrated ability to technically trouble shoot and resolve assay challenges to successfully produce cell therapy products at a high-performance rate.Demonstrated ability to develop, qualify/validate and transfer biologics analytics into manufacturing processes and product testing that meet customer needs is required.Knowledge of method lifecycle management - from early to late-phase and throughout commercialization.Knowledge of cGMP in the pharmaceutical industry. Application to cell/gene therapy and viral vector development/manufacturing a plus.Familiar with data analytics software such as JMP, Minitab, and/or GraphPad Prism.Must have strong interpersonal and communication skills, be a team player and be willing to work in an environment where individual initiative, accountability to the team, and professional maturity are required.Strong problem-solving and organizational skills are required.  skills: Cell Biology, Biology, Chemistry, GLP (Good Laboratory Practice), GMP (Good Manufacturing Practice) Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.EOEDisclaime For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    job summary: This role will lead a multi-functional laboratory team developing analytical (molecular, bioassays, and immuno-assays inclusive) assays to support the development of novel modified autologous and allogeneic cell/gene therapies. The role will also be responsible for preclinical and clinical assay development/ optimization/ qualification to support required testing of cell/gene therapies and viral vectors used in the manufacturing process.   location: Arcadia, California job type: Permanent salary: $130,000 - 150,000 per year work hours: 9 to 5 education: Masters   responsibilities: Expert in analytical assay development adopting the quality-by-design concept to support testing of all pre-clinical and clinical Theragent cell therapy programs.Provide strategic and scientific guidance in all analytical development technical areas; Serve as the analytical development expert on molecular/ biological/ immuno-assays, structure-function relationships, test method development and qualification/ validation, and establishment of specifications, including cell and gene therapy programs.Oversee all analytical development personnel and activities, including laboratory. equipment/instrumentation, execution of testing, and data interpretation of results.Develop method platforms to support current and new product formats, increased product control, lower cost, and lower operational laboratory complexity.Work strategically to accelerate the development and implementation of novel testing technologies for integration into new and existing drug products.Play a key role in project team meetings and decisions working closely with other functions such as Research, Regulatory Affairs, Manufacturing, Quality, Clinical, Finance, Program Management, Business Development, and others.Prepare and present to leadership, external clients, and stakeholders on analytical method development strategy, latest data and conclusions, plans and roadmap to meet client and Theragent testing development goals.Responsible for method LCM; execute on IND development timelines against operational plans.Builds a strong scientific and technical laboratory team, provides necessary training and ongoing coaching, discipline, and recognition of direct staff, including performing annual performance reviews.Support technology transfer of products and processes into the cGMP facility, and serve as a key SME with external laboratory organizations and key clients as well as material/component and equipment/instrument vendors.Investigate and resolve problems, identify root cause, and propose laboratory operation improvements through clear communication to senior management.Interact with outside vendors and senior management.Participate in multi-functional project teams, as necessary.Take corrective action to bring about required changes using approved change control procedures.  qualifications: Masters/Ph. D degree in Biochemistry, Cell Biology, Molecular Biology, Virology, Biological Sciences with 5 - 8 years of experience managing a technical laboratory team in the cell therapy biotechnology industry.Direct experience with cell and gene therapy process development, IND filing, and supporting clinical products expectations is required.In-depth experience and knowledge in biotherapeutics analytics with emphasis on cell-based potency methods, cellular characterization, viral characterization and infectivity assays, molecular methods, antigenicity methods, and other separation-based methods used for gene/cell therapies.Two to three years managing an analytical science or multi-functional bioanalytical laboratory technical team.Familiar with the FDA regulatory requirements for drug products and IND filingKnowledgeable of cGMP processes and technology transfer.Demonstrated ability to design and execute laboratory experiments and evaluate data to provide scientific guidance on assay optimization.Demonstrated ability to technically trouble shoot and resolve assay challenges to successfully produce cell therapy products at a high-performance rate.Demonstrated ability to develop, qualify/validate and transfer biologics analytics into manufacturing processes and product testing that meet customer needs is required.Knowledge of method lifecycle management - from early to late-phase and throughout commercialization.Knowledge of cGMP in the pharmaceutical industry. Application to cell/gene therapy and viral vector development/manufacturing a plus.Familiar with data analytics software such as JMP, Minitab, and/or GraphPad Prism.Must have strong interpersonal and communication skills, be a team player and be willing to work in an environment where individual initiative, accountability to the team, and professional maturity are required.Strong problem-solving and organizational skills are required.  skills: Cell Biology, Biology, Chemistry, GLP (Good Laboratory Practice), GMP (Good Manufacturing Practice) Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.EOEDisclaime For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    • arcadia, california
    • permanent
    • $100,000 - $120,000 per year
    job summary: The QC LIMS Administrator has a unique opportunity to play a key role in development, configuration, validation, implementation and maintenance of the QC LIMS system and processes from ground up for a Cell and Gene therapy biotech startup.   location: Arcadia, California job type: Permanent salary: $100,000 - 120,000 per year work hours: 9 to 5 education: Bachelors   responsibilities: Serve as a project leader in the implementation and roll out of the Company's LIMS platformLiaison with QA, QC, and IT to understand the user requirements and requests and communicate with developers to ensure proper development of the systemDescribe workflow into software requirements, execute and review and validation documentsSet up and organize system specific processesServe as the subject matter expert (SME) on validation requirement, master data setup, reporting, equipment integration, and enterprise systems related to QC LIMSEnsure LIMS system compliance with all relevant regulatory standards and support audits for LIMS specific topicsProvide end user training to operate the systemSupport training and use of LIMS for each functional areaAuthor, revise, implement, and manage LIMS related procedures for administrator and usersCreate and maintain data configurations for users and integration of the instruments to LIMSPartner with IT and external vendors to manage implementation, enhancements, incident investigation, system impact assessments and change controlsLead, develop, and manage QC LIMS related change controls, NC, CAPAsImplement best practices on LIMS development, master data, reporting, and configurationsTrack and troubleshoot LIMS support program issuesCollaborate closely with IT group and stakeholders in developing system infrastructure and database requirementsConduct risk assessments and champion continuous improvementOther duties as assigned by management.  qualifications: Bachelor's degree in Life Sciences, Engineering or Computer ScienceMinimum of 4 years of work experience with LIMS system in the Pharmaceutical, Life Sciences industry with cGMP, GLP. Experience with SampleManager preferred.Experience with problem solving methods such as DMAIC or other similar Root Cause Analysis ToolsStrong knowledge of cGMP and ICH guidelines. Other regulatory agencies experiences preferredSolid understanding of 21CFR part 11 and GAMP5Basic knowledge of Compendial (i.e., USP, EP, JP, etc.) requirements and standardsPrior laboratory experience is a plus, but not required  skills: Biology, GLP (Good Laboratory Practice), ICH Regulations, GMP (Good Manufacturing Practice) Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.EOEDisclaime For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    job summary: The QC LIMS Administrator has a unique opportunity to play a key role in development, configuration, validation, implementation and maintenance of the QC LIMS system and processes from ground up for a Cell and Gene therapy biotech startup.   location: Arcadia, California job type: Permanent salary: $100,000 - 120,000 per year work hours: 9 to 5 education: Bachelors   responsibilities: Serve as a project leader in the implementation and roll out of the Company's LIMS platformLiaison with QA, QC, and IT to understand the user requirements and requests and communicate with developers to ensure proper development of the systemDescribe workflow into software requirements, execute and review and validation documentsSet up and organize system specific processesServe as the subject matter expert (SME) on validation requirement, master data setup, reporting, equipment integration, and enterprise systems related to QC LIMSEnsure LIMS system compliance with all relevant regulatory standards and support audits for LIMS specific topicsProvide end user training to operate the systemSupport training and use of LIMS for each functional areaAuthor, revise, implement, and manage LIMS related procedures for administrator and usersCreate and maintain data configurations for users and integration of the instruments to LIMSPartner with IT and external vendors to manage implementation, enhancements, incident investigation, system impact assessments and change controlsLead, develop, and manage QC LIMS related change controls, NC, CAPAsImplement best practices on LIMS development, master data, reporting, and configurationsTrack and troubleshoot LIMS support program issuesCollaborate closely with IT group and stakeholders in developing system infrastructure and database requirementsConduct risk assessments and champion continuous improvementOther duties as assigned by management.  qualifications: Bachelor's degree in Life Sciences, Engineering or Computer ScienceMinimum of 4 years of work experience with LIMS system in the Pharmaceutical, Life Sciences industry with cGMP, GLP. Experience with SampleManager preferred.Experience with problem solving methods such as DMAIC or other similar Root Cause Analysis ToolsStrong knowledge of cGMP and ICH guidelines. Other regulatory agencies experiences preferredSolid understanding of 21CFR part 11 and GAMP5Basic knowledge of Compendial (i.e., USP, EP, JP, etc.) requirements and standardsPrior laboratory experience is a plus, but not required  skills: Biology, GLP (Good Laboratory Practice), ICH Regulations, GMP (Good Manufacturing Practice) Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.EOEDisclaime For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    • arcadia, california
    • permanent
    • $170,000 - $200,000 per year
    job summary: This individual will be an integral leader of process development for our viral vector program and help advance our client's portfolio of cell therapy products. The individual will be responsible for viral vector process design and development, scale up processes as well as monitoring of the viral manufacturing platforms to support continuous platform advancement opportunities.   location: Arcadia, California job type: Permanent salary: $170,000 - 200,000 per year work hours: 9 to 5 education: Masters   responsibilities: Establish internal analytical capability for vector release, characterization and in-process assay development.Develop and implement state-of-art and innovative viral and non-viral analytical methods to support platform development for Upstream, Downstream, Formulation functional areas, and qualify assaysResponsible for analytical related SOPs, methods, and reports, generate reference standards, assay qualification/validation protocols, and reports related to vector manufacturingEstablish tracking and trending analyses of process development and cGMP production runs, including evaluation of critical reagents and a lot-to-lot variability, in order to improve process standardizationCollaborate closely with other departments to enable effective and successful projectdevelopment; actively engage in cross-functional collaboration with peers to overcomechallengesServe as internal SME on Analytical Analysis and prepare reviews or edit regulatory documents and responses to questions for FDA and/or international agenciesDraft timeline scenarios and develop resource projections to enable pipeline project execution and inform portfolio decisions, including risk assessments, mitigation plans, lessons learned, standard methodologiesParticipate and influence cross-functional development team to advance production activitiesDevelop manufacturing processes for viral vector products and develop process improvements and efficienciesAuthor, review and approve technical documentation, including but not limited to studyprotocols, process development and validation reports and process/manufacturing sections of regulatory documentLead and develop a high-performing team comprised of senior and junior level staff; collaborate cross-functionally within Viral Vector PD organization as well as being a key player in interactions with stakeholders and partner organizationsLead and oversee the design, planning and execution of studies to support cutting edge process design and developmentDevelop and execute process characterization studies to develop a thorough understanding of operating and performance parametersFoster growth and development of staff, including hands-on training if needed  qualifications: MS/PhD in Molecular Biology, biochemistry, chemical/biochemical engineering or related disciplines with a minimum 5+ years of in-depth technical experience in purification process development for viral vectorsKnowledge and experience in purification process engineering and process scale-up/scale-down design is essential.Leadership experience as a successful leader in a strategic multifunctional environment.Strong business acumen and critical thinking.Industry experience in process characterization and validation.Hands-on experience with technology transfer of manufacturing process.Knowledge of cGMP, regulatory guidelines, validation practices, and other relevant regulatory requirements.Excellent interpersonal communication and presentation skills.  skills: Cell Biology, GMP (Good Manufacturing Practice), Process Engineering Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.EOEDisclaime For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    job summary: This individual will be an integral leader of process development for our viral vector program and help advance our client's portfolio of cell therapy products. The individual will be responsible for viral vector process design and development, scale up processes as well as monitoring of the viral manufacturing platforms to support continuous platform advancement opportunities.   location: Arcadia, California job type: Permanent salary: $170,000 - 200,000 per year work hours: 9 to 5 education: Masters   responsibilities: Establish internal analytical capability for vector release, characterization and in-process assay development.Develop and implement state-of-art and innovative viral and non-viral analytical methods to support platform development for Upstream, Downstream, Formulation functional areas, and qualify assaysResponsible for analytical related SOPs, methods, and reports, generate reference standards, assay qualification/validation protocols, and reports related to vector manufacturingEstablish tracking and trending analyses of process development and cGMP production runs, including evaluation of critical reagents and a lot-to-lot variability, in order to improve process standardizationCollaborate closely with other departments to enable effective and successful projectdevelopment; actively engage in cross-functional collaboration with peers to overcomechallengesServe as internal SME on Analytical Analysis and prepare reviews or edit regulatory documents and responses to questions for FDA and/or international agenciesDraft timeline scenarios and develop resource projections to enable pipeline project execution and inform portfolio decisions, including risk assessments, mitigation plans, lessons learned, standard methodologiesParticipate and influence cross-functional development team to advance production activitiesDevelop manufacturing processes for viral vector products and develop process improvements and efficienciesAuthor, review and approve technical documentation, including but not limited to studyprotocols, process development and validation reports and process/manufacturing sections of regulatory documentLead and develop a high-performing team comprised of senior and junior level staff; collaborate cross-functionally within Viral Vector PD organization as well as being a key player in interactions with stakeholders and partner organizationsLead and oversee the design, planning and execution of studies to support cutting edge process design and developmentDevelop and execute process characterization studies to develop a thorough understanding of operating and performance parametersFoster growth and development of staff, including hands-on training if needed  qualifications: MS/PhD in Molecular Biology, biochemistry, chemical/biochemical engineering or related disciplines with a minimum 5+ years of in-depth technical experience in purification process development for viral vectorsKnowledge and experience in purification process engineering and process scale-up/scale-down design is essential.Leadership experience as a successful leader in a strategic multifunctional environment.Strong business acumen and critical thinking.Industry experience in process characterization and validation.Hands-on experience with technology transfer of manufacturing process.Knowledge of cGMP, regulatory guidelines, validation practices, and other relevant regulatory requirements.Excellent interpersonal communication and presentation skills.  skills: Cell Biology, GMP (Good Manufacturing Practice), Process Engineering Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.EOEDisclaime For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    • arcadia, california
    • permanent
    • $170,000 - $200,000 per year
    job summary: This role will be responsible for preclinical development, IND enabling studies, and technology transfer to manufacturing and MSAT, including management of Cell Process Development, Vector Process Development, and Analytical/Bioassay Development. This candidate will also be responsible for clinical process development including process optimization by DOE, QbD, and other statistical based methodologies.   location: Arcadia, California job type: Permanent salary: $170,000 - 200,000 per year work hours: 9 to 5 education: Bachelors   responsibilities: Process Science including, Process Development, Analytical/Bioassay Development and CMC leadership for all pre-clinical and clinical Theragent cell therapy programsOversee all process sciences personnel and activities, including allogeneic/autologous cells, viral vectors, and technology developmentDevelops manufacturing platforms to enable current and new product formats, increased product control, lower cost, and lower operational complexity. - Works strategically to accelerate the development and implementation of novel technologies for integration into new and existing drug product platform processes.Play a key role in project team meetings and decisions working closely with other functions such as Research, Regulatory Affairs, Manufacturing, Quality, Clinical, Finance, Program Management, Business Development, and othersPrepare and present to leadership and external clients and stakeholders on process development strategy, latest data and conclusions, plans and roadmap to meet client and Theragent development goalsExecutes on IND development timelines against operational planBuilds a strong scientific and technical team, provides necessary training and ongoing coaching, discipline, and recognition of direct staff, including performing annual performance reviewsSupports technology transfer of products and processes into the cGMP facility, and serves as a key SME with external manufacturing organizations and key clients as well as material/component and equipment vendorsInvestigates and resolve problems, identifying root cause, and proposing process improvements through clear communication to senior managementInteracts with outside vendors and senior managementParticipates in multi-functional project teams, as necessaryTakes corrective action to bring about required changes using change control procedures  qualifications: Bachelor's degree in immunology, biology, bioengineering, or related field (or equivalent experience required), advanced degree preferredAt least 10 years of experience managing a technical team in the cell therapy biotechnology industryDirect experience with cell and gene therapy process development, IND filing, and supporting clinical products is expectations requiredAt least 5 years managing an analytical science or multi-functional bioanalytical laboratory technical teamMinimum of 5 years' experience in FDA-regulated industry. with 5 years' experience in managing warehouse materials and/or cold chain distribution.  skills: CMC, Cell Biology, IND, GMP (Good Manufacturing Practice), Process Engineering Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.EOEDisclaime For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    job summary: This role will be responsible for preclinical development, IND enabling studies, and technology transfer to manufacturing and MSAT, including management of Cell Process Development, Vector Process Development, and Analytical/Bioassay Development. This candidate will also be responsible for clinical process development including process optimization by DOE, QbD, and other statistical based methodologies.   location: Arcadia, California job type: Permanent salary: $170,000 - 200,000 per year work hours: 9 to 5 education: Bachelors   responsibilities: Process Science including, Process Development, Analytical/Bioassay Development and CMC leadership for all pre-clinical and clinical Theragent cell therapy programsOversee all process sciences personnel and activities, including allogeneic/autologous cells, viral vectors, and technology developmentDevelops manufacturing platforms to enable current and new product formats, increased product control, lower cost, and lower operational complexity. - Works strategically to accelerate the development and implementation of novel technologies for integration into new and existing drug product platform processes.Play a key role in project team meetings and decisions working closely with other functions such as Research, Regulatory Affairs, Manufacturing, Quality, Clinical, Finance, Program Management, Business Development, and othersPrepare and present to leadership and external clients and stakeholders on process development strategy, latest data and conclusions, plans and roadmap to meet client and Theragent development goalsExecutes on IND development timelines against operational planBuilds a strong scientific and technical team, provides necessary training and ongoing coaching, discipline, and recognition of direct staff, including performing annual performance reviewsSupports technology transfer of products and processes into the cGMP facility, and serves as a key SME with external manufacturing organizations and key clients as well as material/component and equipment vendorsInvestigates and resolve problems, identifying root cause, and proposing process improvements through clear communication to senior managementInteracts with outside vendors and senior managementParticipates in multi-functional project teams, as necessaryTakes corrective action to bring about required changes using change control procedures  qualifications: Bachelor's degree in immunology, biology, bioengineering, or related field (or equivalent experience required), advanced degree preferredAt least 10 years of experience managing a technical team in the cell therapy biotechnology industryDirect experience with cell and gene therapy process development, IND filing, and supporting clinical products is expectations requiredAt least 5 years managing an analytical science or multi-functional bioanalytical laboratory technical teamMinimum of 5 years' experience in FDA-regulated industry. with 5 years' experience in managing warehouse materials and/or cold chain distribution.  skills: CMC, Cell Biology, IND, GMP (Good Manufacturing Practice), Process Engineering Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.EOEDisclaime For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    • buena park, california
    • permanent
    • $115,000 - $130,000 per year
    job summary: We are the #1 HR Services Company in the world and we are sourcing for a Sr. Research Scientist in the greater Los Angeles, CA area. The ideal candidate will be passionate about ensuring the sound science of our nutrition products, along with developing relevant and meaningful product and program solutions that address key customer needs in the health and wellness space. This is a direct hire position and can start immediately.   location: Buena Park, California job type: Permanent salary: $115,000 - 130,000 per year work hours: 8 to 4 education: Masters   responsibilities: What's special about this team: The Health Seekers Platform is a cross-functional product development team comprised of formulation, process engineering, package engineering, and nutrition investigations. The team's work focuses on innovation and delivery of new products for our targeted product platform and the 40+ age segment -vision health, bone health, immunity, etc. Working with this technical team, you will develop with an open innovation mindset, working both internally and through external partnerships to offer creative & engaging product offerings. Your teamwork will continue to position the team as the leading direct selling company in the world by offering innovative product solutions for our targeted nutrition category. You will add energy and inspiration to a strong technical team! What's special about this role: As a Senior Nutrition Research & Clinical Investigator on this team, you will evaluate scientific research to support the Nutrilite global product portfolio and provide scientific credibility to differentiate Nutrilite products from competitors. Your role will require you to work on front end research, helping to identify relevant mechanisms of action and outcomes, and to partner with internal teams and/or external partners to advance ingredient and product technologies. If clinical studies are warranted, you will develop protocols, identify the appropriate CRO or academic partner, oversee study execution and results analysis, and then translate the results into consumer-friendly and regulatory acceptable claims and stories which support the efficacy of our products. Your background in both nutrition science and clinical research will be showcased in the role. Your work will maintain the high credibility of the Nutrilite brand and will offer a highly visible role, providing patent and publication opportunities, in addition to the ability to travel globally, meeting and sharing expert insights about Nutrilite products, nutrition, and health. If you have a passion for health and wellness, enjoy translating complex nutrition science into efficacious, experiential products, and the ability to share your expertise with clients and customers around the world, this role can offer a strong platform to spotlight your talent!   qualifications: Required qualifications: Minimum 3 - 6 years of experience in nutrition research and product claim substantiationAdvanced degree (MS or PhD) in Bioscience, Nutrition Science, or related scientific discipline Skills to be successful in the role:Proven exposures incorporating functional botanicals and botanically derived bioactives into product profile designAbility to translate complex scientific and technical concepts into consumer appropriate language, ideally with compelling visuals, to enable communication and understanding of the science underlying the productInterpersonal skills to influence and inspire both internal and external audiencesExperience leading clinical studies in an industry setting is helpfulBasic understanding of global regulations in the nutraceutical industry is preferredIndustry awareness with knowledge of trends and innovation desiredRD (Registered Dietician) Certification, ACRP (Association of Clinical Research Professionals) Certification, or naturopathic background helpful  skills: Molecular Biology, Cell Biology, HPLC, Pharmacology, Toxicology, Data Analysis, ADME, Assay Development, Assay Method, Assay Verification, Biology, Chemistry, Chromatography, GLP (Good Laboratory Practice), Metrology, Microbiology, Laboratory Information Management Systems (LIMS), Protein Purification, Cell Cultures Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.EOEDisclaime For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    job summary: We are the #1 HR Services Company in the world and we are sourcing for a Sr. Research Scientist in the greater Los Angeles, CA area. The ideal candidate will be passionate about ensuring the sound science of our nutrition products, along with developing relevant and meaningful product and program solutions that address key customer needs in the health and wellness space. This is a direct hire position and can start immediately.   location: Buena Park, California job type: Permanent salary: $115,000 - 130,000 per year work hours: 8 to 4 education: Masters   responsibilities: What's special about this team: The Health Seekers Platform is a cross-functional product development team comprised of formulation, process engineering, package engineering, and nutrition investigations. The team's work focuses on innovation and delivery of new products for our targeted product platform and the 40+ age segment -vision health, bone health, immunity, etc. Working with this technical team, you will develop with an open innovation mindset, working both internally and through external partnerships to offer creative & engaging product offerings. Your teamwork will continue to position the team as the leading direct selling company in the world by offering innovative product solutions for our targeted nutrition category. You will add energy and inspiration to a strong technical team! What's special about this role: As a Senior Nutrition Research & Clinical Investigator on this team, you will evaluate scientific research to support the Nutrilite global product portfolio and provide scientific credibility to differentiate Nutrilite products from competitors. Your role will require you to work on front end research, helping to identify relevant mechanisms of action and outcomes, and to partner with internal teams and/or external partners to advance ingredient and product technologies. If clinical studies are warranted, you will develop protocols, identify the appropriate CRO or academic partner, oversee study execution and results analysis, and then translate the results into consumer-friendly and regulatory acceptable claims and stories which support the efficacy of our products. Your background in both nutrition science and clinical research will be showcased in the role. Your work will maintain the high credibility of the Nutrilite brand and will offer a highly visible role, providing patent and publication opportunities, in addition to the ability to travel globally, meeting and sharing expert insights about Nutrilite products, nutrition, and health. If you have a passion for health and wellness, enjoy translating complex nutrition science into efficacious, experiential products, and the ability to share your expertise with clients and customers around the world, this role can offer a strong platform to spotlight your talent!   qualifications: Required qualifications: Minimum 3 - 6 years of experience in nutrition research and product claim substantiationAdvanced degree (MS or PhD) in Bioscience, Nutrition Science, or related scientific discipline Skills to be successful in the role:Proven exposures incorporating functional botanicals and botanically derived bioactives into product profile designAbility to translate complex scientific and technical concepts into consumer appropriate language, ideally with compelling visuals, to enable communication and understanding of the science underlying the productInterpersonal skills to influence and inspire both internal and external audiencesExperience leading clinical studies in an industry setting is helpfulBasic understanding of global regulations in the nutraceutical industry is preferredIndustry awareness with knowledge of trends and innovation desiredRD (Registered Dietician) Certification, ACRP (Association of Clinical Research Professionals) Certification, or naturopathic background helpful  skills: Molecular Biology, Cell Biology, HPLC, Pharmacology, Toxicology, Data Analysis, ADME, Assay Development, Assay Method, Assay Verification, Biology, Chemistry, Chromatography, GLP (Good Laboratory Practice), Metrology, Microbiology, Laboratory Information Management Systems (LIMS), Protein Purification, Cell Cultures Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.EOEDisclaime For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    • lake forest, california
    • contract
    • $80 - $85.71 per hour
    job summary: As the world's largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. We supply prestigious life sciences and biopharma companies with job seekers like you to achieve their business goals. If you're looking for a position where you can serve as an asset to your company while making a difference in others' lives, we have the ideal position for you!   location: Lake Forest, California job type: Contract salary: $80.00 - 85.71 per hour work hours: 9 to 5 education: Associate   responsibilities: Review of documents to support continued market access of Company medical device products Assist colleagues in preparation of clinical focused regulatory documents and agreements Participation in Cross Functional team meetings on product development and regulatory documents Review literature and assist in creation of abstracts, presentations and publications of Company internal studies/Company sponsored studies Creation of documents as references for summary of Company internal studies  qualifications: Bachelor's Degree or equivalent years of directly related experience; (Assoc.+9 yrs; M.S.+2 yrs; PhD+0 yrs)MEDICAL DEVICEREGULATORY DOCUMENTSMEDICAL WRITINGCDMAThe ability to fluently read, write, understand and communicate in English5 Years of Relevant ExperienceLifecycle Management experience, understanding of documents required for CE Marking Ophthalmic experience strongly desired, especially in posterior segment Medical writing a plus  skills: GCP (Good Clinical Practice), Regulatory Briefing Documents, Submissions Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance. We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    job summary: As the world's largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. We supply prestigious life sciences and biopharma companies with job seekers like you to achieve their business goals. If you're looking for a position where you can serve as an asset to your company while making a difference in others' lives, we have the ideal position for you!   location: Lake Forest, California job type: Contract salary: $80.00 - 85.71 per hour work hours: 9 to 5 education: Associate   responsibilities: Review of documents to support continued market access of Company medical device products Assist colleagues in preparation of clinical focused regulatory documents and agreements Participation in Cross Functional team meetings on product development and regulatory documents Review literature and assist in creation of abstracts, presentations and publications of Company internal studies/Company sponsored studies Creation of documents as references for summary of Company internal studies  qualifications: Bachelor's Degree or equivalent years of directly related experience; (Assoc.+9 yrs; M.S.+2 yrs; PhD+0 yrs)MEDICAL DEVICEREGULATORY DOCUMENTSMEDICAL WRITINGCDMAThe ability to fluently read, write, understand and communicate in English5 Years of Relevant ExperienceLifecycle Management experience, understanding of documents required for CE Marking Ophthalmic experience strongly desired, especially in posterior segment Medical writing a plus  skills: GCP (Good Clinical Practice), Regulatory Briefing Documents, Submissions Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance. We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    • woodland, california
    • temporary
    • $20 - $24 per hour
    Randstad is seeking experienced Lab Technicians to work in a Seed Quality Health lab. This position is with our client, a global life sciences company focused in agricultural research.  This position will provide an opportunity to learn new test methods and production systems.A Bachelor's degree in a scientific discipline is required for this position with at least 1 year of post graduate lab/research experience.  You will need to be organized, dependable, demonstrate good time management, have an excellent attention to detail, and is a supportive team member.salary: $20 - $24 per hourshift: Firstwork hours: 7 AM - 3:30 PMeducation: BachelorResponsibilitiesAs the successful candidate, you will work with a Sample Management team. The primary job function revolves around the processing of seed samples including counting/prepping seed, dishwashing, and making buffer and media. Normal daily activities may include the following: seed sample preparation, maintaining equipment and lab inventory; maintaining stocks of buffers, media and other reagents; word/excel data entry and LIMS database management; and running routine greenhouse or laboratory tests. You will maintain lab supplies, safety standards, documents and will also help in other seed health groups with routine testing.Skills Buffer Preparation (1 year of experience is required)Sample Preparation (1 year of experience is required)Greenhouse (1 year of experience is required)Sample Testing (1 year of experience is preferred)LIMS (1 year of experience is required)Microsoft Office (5 years of experience is required) Qualifications Years of experience: 1 yearExperience level: Experienced Randstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad.Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance. We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    Randstad is seeking experienced Lab Technicians to work in a Seed Quality Health lab. This position is with our client, a global life sciences company focused in agricultural research.  This position will provide an opportunity to learn new test methods and production systems.A Bachelor's degree in a scientific discipline is required for this position with at least 1 year of post graduate lab/research experience.  You will need to be organized, dependable, demonstrate good time management, have an excellent attention to detail, and is a supportive team member.salary: $20 - $24 per hourshift: Firstwork hours: 7 AM - 3:30 PMeducation: BachelorResponsibilitiesAs the successful candidate, you will work with a Sample Management team. The primary job function revolves around the processing of seed samples including counting/prepping seed, dishwashing, and making buffer and media. Normal daily activities may include the following: seed sample preparation, maintaining equipment and lab inventory; maintaining stocks of buffers, media and other reagents; word/excel data entry and LIMS database management; and running routine greenhouse or laboratory tests. You will maintain lab supplies, safety standards, documents and will also help in other seed health groups with routine testing.Skills Buffer Preparation (1 year of experience is required)Sample Preparation (1 year of experience is required)Greenhouse (1 year of experience is required)Sample Testing (1 year of experience is preferred)LIMS (1 year of experience is required)Microsoft Office (5 years of experience is required) Qualifications Years of experience: 1 yearExperience level: Experienced Randstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad.Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance. We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    • lake forest, california
    • contract
    • $38 - $43.48 per hour
    job summary: As the world's largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. We supply prestigious life sciences and biopharma companies with job seekers like you to achieve their business goals. If you're looking for a position where you can serve as an asset to your company while making a difference in others' lives, we have the ideal position for you!   location: Lake Forest, California job type: Contract salary: $38.00 - 43.48 per hour work hours: 9 to 5 education: Bachelors   responsibilities: Assist with preparing technical documents, legalized documents and letters in support of international regulatory submissions.Assist with set-up and preparation of EU Technical Files.Organize and support renewals of international licenses.Support various activities associated with implementation of the EU Medical Device Regulation.  qualifications: Bachelor's degree or 5 years equivalent experience in medical devices. Excellent writing skills.Regulatory affairs knowledge and experience in medical devices.Self-starter with ability to work independently on basic tasks and under direction by more experienced staff on more complex assignments/tasks.Proficient in MS Office applications.Ability to work hours outside 8am-5pm Pacific time in order to support international colleagues is preferred. Proficiency in Veeva application desired.  skills: MS-WORD, MS-EXCEL, MS-Powerpoint, Submissions Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance. We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    job summary: As the world's largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. We supply prestigious life sciences and biopharma companies with job seekers like you to achieve their business goals. If you're looking for a position where you can serve as an asset to your company while making a difference in others' lives, we have the ideal position for you!   location: Lake Forest, California job type: Contract salary: $38.00 - 43.48 per hour work hours: 9 to 5 education: Bachelors   responsibilities: Assist with preparing technical documents, legalized documents and letters in support of international regulatory submissions.Assist with set-up and preparation of EU Technical Files.Organize and support renewals of international licenses.Support various activities associated with implementation of the EU Medical Device Regulation.  qualifications: Bachelor's degree or 5 years equivalent experience in medical devices. Excellent writing skills.Regulatory affairs knowledge and experience in medical devices.Self-starter with ability to work independently on basic tasks and under direction by more experienced staff on more complex assignments/tasks.Proficient in MS Office applications.Ability to work hours outside 8am-5pm Pacific time in order to support international colleagues is preferred. Proficiency in Veeva application desired.  skills: MS-WORD, MS-EXCEL, MS-Powerpoint, Submissions Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance. We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    • lake forest, california
    • contract
    • $25 - $30 per hour
    job summary: As the world's largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. We supply prestigious life sciences and biopharma companies with job seekers like you to achieve their business goals. If you're looking for a position where you can serve as an asset to your company while making a difference in others' lives, we have the ideal position for you!   location: Lake Forest, California job type: Contract salary: $25 - 30 per hour work hours: 9 to 5 education: Bachelors   responsibilities: Assist with preparing and coordinating documents to be legalized in support of international regulatory submissions.Support and prepare technical documents for international registrations.Support Regulatory Affairs organization by processing invoices, processing legal documents, ordering supplies, and performing other administrative activities as needed.  qualifications: Bachelor's degree or equivalent experience is preferred.Self-starter with ability to work independently under pressure and react quickly to changing priorities.Proficient in MS Office applications.Ability to work hours outside 8am-5pm Pacific Time in order to support international colleagues is preferred.Licensed notary by the State of California is preferred.Knowledge/experience of medical devices is preferred.   skills: MS-WORD, MS-EXCEL, MS-Powerpoint Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance. We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    job summary: As the world's largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. We supply prestigious life sciences and biopharma companies with job seekers like you to achieve their business goals. If you're looking for a position where you can serve as an asset to your company while making a difference in others' lives, we have the ideal position for you!   location: Lake Forest, California job type: Contract salary: $25 - 30 per hour work hours: 9 to 5 education: Bachelors   responsibilities: Assist with preparing and coordinating documents to be legalized in support of international regulatory submissions.Support and prepare technical documents for international registrations.Support Regulatory Affairs organization by processing invoices, processing legal documents, ordering supplies, and performing other administrative activities as needed.  qualifications: Bachelor's degree or equivalent experience is preferred.Self-starter with ability to work independently under pressure and react quickly to changing priorities.Proficient in MS Office applications.Ability to work hours outside 8am-5pm Pacific Time in order to support international colleagues is preferred.Licensed notary by the State of California is preferred.Knowledge/experience of medical devices is preferred.   skills: MS-WORD, MS-EXCEL, MS-Powerpoint Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance. We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    • irvine, california
    • contract
    • $35 - $40.52 per hour
    job summary: As the world's largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. A current top partnership with a research-driven biopharmaceutical company is known as a powerhouse that aims to develop treatments for difficult-to-cure diseases. This renowned employer has created 32 products, including Humira and Lupron, that have highly impacted lives across the globe. If you're looking to stand out in your field and lead the way to innovative therapies, this position is for you! This role requires employees to be fully vaccinated against COVID-19 as a condition of employment, subject to a valid medical or religious accommodation.   location: Irvine, California job type: Contract salary: $35.00 - 40.52 per hour work hours: 9 to 5 education: Bachelors   responsibilities: Looking for a team player with strong QC lab experience in a cGMP environment.   qualifications: Bachelor's degree (or above) in biology or chemistry strongly preferred, with 6-10 years industry experience;Six to ten years' experience in the lab in chemistry in a GMP pharmaceutical manufacturing and/or development environment.Industry experience in chromatography data collection/processing software. Empower preferred.Industry experience in GMP documentation and working in a GMP environment.Experience with release and stability analytical data reviewFamiliarity with TrackWise preferredExperience with investigations and non-conformance writing and reviewAbility to work closely with QC analysts to generate Standard Operating Procedures, protocols and reports, including validation protocols and reportsAbility execute laboratory testing, if needed, to support the QC lab activities  skills: Quality control, GMP (Good Manufacturing Practice) Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance. We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    job summary: As the world's largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. A current top partnership with a research-driven biopharmaceutical company is known as a powerhouse that aims to develop treatments for difficult-to-cure diseases. This renowned employer has created 32 products, including Humira and Lupron, that have highly impacted lives across the globe. If you're looking to stand out in your field and lead the way to innovative therapies, this position is for you! This role requires employees to be fully vaccinated against COVID-19 as a condition of employment, subject to a valid medical or religious accommodation.   location: Irvine, California job type: Contract salary: $35.00 - 40.52 per hour work hours: 9 to 5 education: Bachelors   responsibilities: Looking for a team player with strong QC lab experience in a cGMP environment.   qualifications: Bachelor's degree (or above) in biology or chemistry strongly preferred, with 6-10 years industry experience;Six to ten years' experience in the lab in chemistry in a GMP pharmaceutical manufacturing and/or development environment.Industry experience in chromatography data collection/processing software. Empower preferred.Industry experience in GMP documentation and working in a GMP environment.Experience with release and stability analytical data reviewFamiliarity with TrackWise preferredExperience with investigations and non-conformance writing and reviewAbility to work closely with QC analysts to generate Standard Operating Procedures, protocols and reports, including validation protocols and reportsAbility execute laboratory testing, if needed, to support the QC lab activities  skills: Quality control, GMP (Good Manufacturing Practice) Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance. We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    • berkeley, california
    • contract
    • $26.38 - $31.03 per hour
    job summary: As the world's largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. We supply prestigious life sciences and biopharma companies with job seekers like you to achieve their business goals. If you're looking for a position where you can serve as an asset to your company while making a difference in others' lives, we have the ideal position for you!   location: Berkeley, California job type: Contract salary: $26.38 - 31.03 per hour work hours: 9 to 5 education: Bachelors   responsibilities: Contract position is available to support QC Chemistry II group for release testing, method transfers to other equipment, equipment transfers from ESE to B88. Contractor will support testing, documentation, and general lab duties. Quality Control department, Chemistry group that performs testing on proteins. Testing is HPLC-based. Perform analytical testing to support the release, stability, and in process testing samples, or final products;Follow, accurately, relevant standard operating procedures (SOPs), perform all activities in accordance with certified good manufacturing practice (cGMP) requirements reports abnormalitiesInitiate and complete laboratory discrepancy events on timeKeep accurate documentation and track recordCompile, enter and review data into LIMS or other databases/Excel sheetsConfirm documents test results to ensure completeness and accuracy per cGMPs  qualifications: Required: Bachelor's degree in a scientific disciplineExperience with a cGMPExperience with chromatography systemsAbility to multi-task and good adaptabilityFocus on GoalsIntegrity and Commitment to Company Beliefs and Values Preferred: Experience with Wet-Chemical techniquesExperience with Chromatography  skills: Quality control, HPLC, SOP, MS-EXCEL, Chromatography, Protein Purification, GMP (Good Manufacturing Practice), LIMS (Laboratory Information Management System Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance. We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    job summary: As the world's largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. We supply prestigious life sciences and biopharma companies with job seekers like you to achieve their business goals. If you're looking for a position where you can serve as an asset to your company while making a difference in others' lives, we have the ideal position for you!   location: Berkeley, California job type: Contract salary: $26.38 - 31.03 per hour work hours: 9 to 5 education: Bachelors   responsibilities: Contract position is available to support QC Chemistry II group for release testing, method transfers to other equipment, equipment transfers from ESE to B88. Contractor will support testing, documentation, and general lab duties. Quality Control department, Chemistry group that performs testing on proteins. Testing is HPLC-based. Perform analytical testing to support the release, stability, and in process testing samples, or final products;Follow, accurately, relevant standard operating procedures (SOPs), perform all activities in accordance with certified good manufacturing practice (cGMP) requirements reports abnormalitiesInitiate and complete laboratory discrepancy events on timeKeep accurate documentation and track recordCompile, enter and review data into LIMS or other databases/Excel sheetsConfirm documents test results to ensure completeness and accuracy per cGMPs  qualifications: Required: Bachelor's degree in a scientific disciplineExperience with a cGMPExperience with chromatography systemsAbility to multi-task and good adaptabilityFocus on GoalsIntegrity and Commitment to Company Beliefs and Values Preferred: Experience with Wet-Chemical techniquesExperience with Chromatography  skills: Quality control, HPLC, SOP, MS-EXCEL, Chromatography, Protein Purification, GMP (Good Manufacturing Practice), LIMS (Laboratory Information Management System Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance. We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    • los angeles, california
    • permanent
    • $110,000 - $124,000 per year
    job summary: Exciting opportunity to join a renowned laboratory as a CLS! The Clinical Laboratory Scientist (CLS) will perform moderate and high complexity laboratory testing per CLIA regulations. The CLS will be responsible for performing pre-analytic, analytic, and post-analytic laboratory testing according to established policies and procedures in the Molecular Laboratory.   location: Los Angeles, California job type: Permanent salary: $110,000 - 124,000 per year work hours: 3 to 11 education: Bachelors   responsibilities: Performs molecular and non-molecular laboratory tests according to written laboratory procedure, evaluates test results for accuracy and clinical significance. Reports test results. Tests include various molecular assays / panels for pathogen detection.Actively participates in the planning and execution of analytical and clinical validations for new molecular / clinical tests.Monitors test analyses and specimen examinations to ensure acceptable levels of analytic performance are maintained.Ensure that patient test results are not reported until all corrective actions have been taken and test systems are properly functioning.Adheres to all regulatory standards (CAP and CLIA)  qualifications: Bachelor's degree (BS) in Life Sciences fieldBoard of Certification (BOC) by the American Society of Clinical Pathologists (ASCP)CLS California License (Required)Basic knowledge and experience with molecular platform. (Hologic, Applied Biosystems, BioFire, etc.)Experience with DNA extraction methods and Qualitative PCRExperience with EIAsExperience with initial validation studies desirable.Knowledge and experience using Microsoft Office Applications  skills: Molecular Biology, PCR Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.EOEDisclaime For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    job summary: Exciting opportunity to join a renowned laboratory as a CLS! The Clinical Laboratory Scientist (CLS) will perform moderate and high complexity laboratory testing per CLIA regulations. The CLS will be responsible for performing pre-analytic, analytic, and post-analytic laboratory testing according to established policies and procedures in the Molecular Laboratory.   location: Los Angeles, California job type: Permanent salary: $110,000 - 124,000 per year work hours: 3 to 11 education: Bachelors   responsibilities: Performs molecular and non-molecular laboratory tests according to written laboratory procedure, evaluates test results for accuracy and clinical significance. Reports test results. Tests include various molecular assays / panels for pathogen detection.Actively participates in the planning and execution of analytical and clinical validations for new molecular / clinical tests.Monitors test analyses and specimen examinations to ensure acceptable levels of analytic performance are maintained.Ensure that patient test results are not reported until all corrective actions have been taken and test systems are properly functioning.Adheres to all regulatory standards (CAP and CLIA)  qualifications: Bachelor's degree (BS) in Life Sciences fieldBoard of Certification (BOC) by the American Society of Clinical Pathologists (ASCP)CLS California License (Required)Basic knowledge and experience with molecular platform. (Hologic, Applied Biosystems, BioFire, etc.)Experience with DNA extraction methods and Qualitative PCRExperience with EIAsExperience with initial validation studies desirable.Knowledge and experience using Microsoft Office Applications  skills: Molecular Biology, PCR Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.EOEDisclaime For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    • burlingame, california
    • contract
    • $25 - $28 per hour
    job summary: The Production Lab Assistant will be responsible for assisting in daily clinical operations, primarily involving the performance of a novel clinical test for the testing of COVID-19 in a high complexity CLIA-certified laboratory. Your work will have a direct impact on people's lives by scaling up the availability of COVID-19 testing and developing much needed public health infrastructure. Position Type: Contract position for three (3) months. Schedule/Shift: 3rd shift, 10pm-6 a.m. Monday-Friday   location: Burlingame, California job type: Contract salary: $25 - 28 per hour work hours: 11 to 7 education: Bachelors   responsibilities: Perform specimen receipt and accessioningScan, archive or dispose of documents and records according to company's proceduresDocument all corrective actions taken when there is a deviation to the test systemAssist in troubleshooting issues as assigned.Escalate issues to supervisors for timely resolutionReport all potential problems with PHI and/or HIPAA compliance immediately to supervisorAssist in the general upkeep of the laboratory to support daily operationsMaintain sufficient inventory of supplies for daily operationsClean workbenches, racks, sample containers and other laboratory suppliesDemonstrate understanding of regulatory requirements specific to the assigned work areasIdentify and implement process or quality improvement tasks under Supervisor's guidanceInteract with Support, courier services, other departments to obtain or provide required informationUphold company mission and values through accountability, innovation, integrity, quality, and teamworkSupport and comply with the company's Quality Management, System Policies, and procedures  qualifications: Bachelor's Degree (BS) requiredBasic knowledge in using a PC, printer, barcode labels & scanners, and document scannersExperience with GSuite, Microsoft Excel and WordExcellent organizational, communication and interpersonal skillsStrong verbal and written communication skills Ability to learn and follow written proceduresAbility to identify issues and troubleshoot or escalate, as necessaryAbility to work a designated schedule and adapt to changes in workflowAbility to comply with any applicable personal protective equipment requirementsAbility to lift up to 40lbs  skills: GLP (Good Laboratory Practice) Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance. We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    job summary: The Production Lab Assistant will be responsible for assisting in daily clinical operations, primarily involving the performance of a novel clinical test for the testing of COVID-19 in a high complexity CLIA-certified laboratory. Your work will have a direct impact on people's lives by scaling up the availability of COVID-19 testing and developing much needed public health infrastructure. Position Type: Contract position for three (3) months. Schedule/Shift: 3rd shift, 10pm-6 a.m. Monday-Friday   location: Burlingame, California job type: Contract salary: $25 - 28 per hour work hours: 11 to 7 education: Bachelors   responsibilities: Perform specimen receipt and accessioningScan, archive or dispose of documents and records according to company's proceduresDocument all corrective actions taken when there is a deviation to the test systemAssist in troubleshooting issues as assigned.Escalate issues to supervisors for timely resolutionReport all potential problems with PHI and/or HIPAA compliance immediately to supervisorAssist in the general upkeep of the laboratory to support daily operationsMaintain sufficient inventory of supplies for daily operationsClean workbenches, racks, sample containers and other laboratory suppliesDemonstrate understanding of regulatory requirements specific to the assigned work areasIdentify and implement process or quality improvement tasks under Supervisor's guidanceInteract with Support, courier services, other departments to obtain or provide required informationUphold company mission and values through accountability, innovation, integrity, quality, and teamworkSupport and comply with the company's Quality Management, System Policies, and procedures  qualifications: Bachelor's Degree (BS) requiredBasic knowledge in using a PC, printer, barcode labels & scanners, and document scannersExperience with GSuite, Microsoft Excel and WordExcellent organizational, communication and interpersonal skillsStrong verbal and written communication skills Ability to learn and follow written proceduresAbility to identify issues and troubleshoot or escalate, as necessaryAbility to work a designated schedule and adapt to changes in workflowAbility to comply with any applicable personal protective equipment requirementsAbility to lift up to 40lbs  skills: GLP (Good Laboratory Practice) Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance. We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    • south san francisco, california
    • contract
    • $40 - $48.40 per hour
    job summary: As the world's largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. A current top partnership with a research-driven biopharmaceutical company is known as a powerhouse that aims to develop treatments for difficult-to-cure diseases. This renowned employer has created 32 products, including Humira and Lupron, that have highly impacted lives across the globe. If you're looking to stand out in your field and lead the way to innovative therapies, this position is for you! This role requires employees to be fully vaccinated against COVID-19 as a condition of employment, subject to a valid medical or religious accommodation.   location: South San Francisco, California job type: Contract salary: $40.00 - 48.40 per hour work hours: 9 to 5 education: Bachelors   responsibilities: Serve as the technical lead for in vivo biomedical testing, demonstrating technical proficiency in rodent dosing by various routes (IV, IP, SC, PO)Responsible for the development and validation of animal models for the pharmacokinetic, efficacy, and toxicity evaluation of pharmaceutical candidatesIndependently conduct biomedical studies, accurately document findings, analyze data and prepare reports for internal and external disseminationFlexible hours that will require some weekend and holiday work as well as early am and pm dosing responsibilitiesResponsible for animal care and handling  qualifications: Bachelor's degree in biology, toxicology, pharmacology or related disciplines, or 3 or more years relevant experience Preferred Skills/Abilities: Experience with IACUC policies and proceduresPractical knowledge of Good Laboratory Practice regulations desiredAbility to recognize and respond appropriately to both anticipated and unanticipated results during the development and conduct of in vivo studies individually and as part of a teamExcellent oral and written communication skills, self-motivated, highly organized, and able to work independently in a fast-paced research environment  skills: Pharmacology, Biology, In Vivo Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance. We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    job summary: As the world's largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. A current top partnership with a research-driven biopharmaceutical company is known as a powerhouse that aims to develop treatments for difficult-to-cure diseases. This renowned employer has created 32 products, including Humira and Lupron, that have highly impacted lives across the globe. If you're looking to stand out in your field and lead the way to innovative therapies, this position is for you! This role requires employees to be fully vaccinated against COVID-19 as a condition of employment, subject to a valid medical or religious accommodation.   location: South San Francisco, California job type: Contract salary: $40.00 - 48.40 per hour work hours: 9 to 5 education: Bachelors   responsibilities: Serve as the technical lead for in vivo biomedical testing, demonstrating technical proficiency in rodent dosing by various routes (IV, IP, SC, PO)Responsible for the development and validation of animal models for the pharmacokinetic, efficacy, and toxicity evaluation of pharmaceutical candidatesIndependently conduct biomedical studies, accurately document findings, analyze data and prepare reports for internal and external disseminationFlexible hours that will require some weekend and holiday work as well as early am and pm dosing responsibilitiesResponsible for animal care and handling  qualifications: Bachelor's degree in biology, toxicology, pharmacology or related disciplines, or 3 or more years relevant experience Preferred Skills/Abilities: Experience with IACUC policies and proceduresPractical knowledge of Good Laboratory Practice regulations desiredAbility to recognize and respond appropriately to both anticipated and unanticipated results during the development and conduct of in vivo studies individually and as part of a teamExcellent oral and written communication skills, self-motivated, highly organized, and able to work independently in a fast-paced research environment  skills: Pharmacology, Biology, In Vivo Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance. We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    • carpinteria, california
    • permanent
    • $70,000 - $73,000 per year
    job summary: Job Summary: Works independently under close superv7ision, qualify and validate equipment, instruments, and systems. Develop validation plans, protocols, and testing specifications. Analyze validation reports and make recommendations for changes and/or improvements. Assist in the selection of equipment and systems and negotiate competitive pricing. Work with regulatory agencies on inspections. This position will be responsible for performing validation activities to optimize quality assurance (QA) testing processes. This is a hand-on position working cross functionally with Production, Quality, and Technology & Innovation groups to effectively document testing capability.   location: Carpinteria, California job type: Permanent salary: $70,000 - 73,000 per year work hours: 9 to 5 education: Bachelors   responsibilities: What does the position do? Consult with associates and supervisors as to specific safety, chemical, or handling concerns.Perform test method validation activities, including receiving and/or providing training, procuring materials and supplies, performing testing, and documenting results.Interface effectively with management personnel in IT, Engineering, Quality, R&D, and other technical disciplines.Assist in provide technical decision-making regarding validation strategies and requirements.Contribute to the creation of Standard Operating Procedures and training materials.Author and approve basic validation plans, validation protocols, risk assessments, traceability matrices, validation reports, and other documents supporting validation for new and existing manufacturing equipment and processes.Perform and coordinate and manage instrument/equipment qualification testing.Help to coordinate the DQ, IQ, OQ, PQ and PV of all validation activities to assure compliance with customer requirements, ISO 9001 / ISO 13485, 21 CFR 210 & 211and 21CFR 820.Identify any areas for improvement and propose and / implement approved necessary changes.Prepares, writes and reviews basic validation protocols and documentation to ensure compliance and adherence to AMRESCO's SOP's, Customer specifications, ISO9001, ISO 13485, 21 CFR 210 & 211, 21CFR 820 and other applicable regulations. This includes regulatory bodies in the US and International.Maintains all Validations and assures they are updated as required. Periodic review is established based on a data review of quality inputs and outputs to assure outcome is as expected.Consult with associates and supervisors as to specific safety, chemical, or handling concerns.Assists in reviewing need for validation with design group for all processes, equipment and , methods. etc.Support QA department as needed.Performs other duties as assigned. What do you need to have? Bachelor's degree in Engineering, Material Science or Life Science (Chemistry, Biology, Physics, etc.); work experience may be considered in lieu of degree0-3 years applicable experience  qualifications: What would be nice to have? Excellent communications skills, both oral and written.Excellent analytical, statistical, and strategic thinking skills.Strong knowledge and skill in the use of MS Office suite; experience with statistical software products (Minitab, SAS, etc.) is preferred.Must be proactive and independent in daily operation.Knowledge of Industrial Quality Control, Quality Engineering, Quality Assurance and Validation, CFRs and their application to Medical Devices or BiopharmaKnowledge of statistical data analysis, word processing, flow charting, and project managementFamiliarity and understanding of manufacturing methods related to the production of medical devices and related productsFamiliarity and understanding of technical disciplines related to Quality Control and Quality Assurance, including Engineering and process controlsGood communication skills, both verbal and writtenAbility to work independently and as a team member, as well as, with Consultants/Contractors to achieve projects' validation objectives What's the environment like? Typically works in an office environment with adequate lighting and ventilation and a normal range of temperature and noise level.Work assignments are diversified. Examples of past precedent are used to resolve work problems. New alternatives may be developed to resolve problems.A frequent volume of work and deadlines impose strain on routine basis.Minimal physical effort is required. Work is mostly sedentary but does require walking, standing, bending, reaching, lifting or carrying objects that typically weigh less than 10 lbs.Although the associate primarily works in an office environment, while performing the duties of this job, the associate is exposed to a production environment. The associate may work near moving mechanical machinery and/or vehicles and the noise level in the work environment can be loud. While performing the duties of this Job, the employee is occasionally exposed to fumes or airborne particles and toxic or caustic chemicals.  skills: Biology, Chemistry Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.EOEDisclaime For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    job summary: Job Summary: Works independently under close superv7ision, qualify and validate equipment, instruments, and systems. Develop validation plans, protocols, and testing specifications. Analyze validation reports and make recommendations for changes and/or improvements. Assist in the selection of equipment and systems and negotiate competitive pricing. Work with regulatory agencies on inspections. This position will be responsible for performing validation activities to optimize quality assurance (QA) testing processes. This is a hand-on position working cross functionally with Production, Quality, and Technology & Innovation groups to effectively document testing capability.   location: Carpinteria, California job type: Permanent salary: $70,000 - 73,000 per year work hours: 9 to 5 education: Bachelors   responsibilities: What does the position do? Consult with associates and supervisors as to specific safety, chemical, or handling concerns.Perform test method validation activities, including receiving and/or providing training, procuring materials and supplies, performing testing, and documenting results.Interface effectively with management personnel in IT, Engineering, Quality, R&D, and other technical disciplines.Assist in provide technical decision-making regarding validation strategies and requirements.Contribute to the creation of Standard Operating Procedures and training materials.Author and approve basic validation plans, validation protocols, risk assessments, traceability matrices, validation reports, and other documents supporting validation for new and existing manufacturing equipment and processes.Perform and coordinate and manage instrument/equipment qualification testing.Help to coordinate the DQ, IQ, OQ, PQ and PV of all validation activities to assure compliance with customer requirements, ISO 9001 / ISO 13485, 21 CFR 210 & 211and 21CFR 820.Identify any areas for improvement and propose and / implement approved necessary changes.Prepares, writes and reviews basic validation protocols and documentation to ensure compliance and adherence to AMRESCO's SOP's, Customer specifications, ISO9001, ISO 13485, 21 CFR 210 & 211, 21CFR 820 and other applicable regulations. This includes regulatory bodies in the US and International.Maintains all Validations and assures they are updated as required. Periodic review is established based on a data review of quality inputs and outputs to assure outcome is as expected.Consult with associates and supervisors as to specific safety, chemical, or handling concerns.Assists in reviewing need for validation with design group for all processes, equipment and , methods. etc.Support QA department as needed.Performs other duties as assigned. What do you need to have? Bachelor's degree in Engineering, Material Science or Life Science (Chemistry, Biology, Physics, etc.); work experience may be considered in lieu of degree0-3 years applicable experience  qualifications: What would be nice to have? Excellent communications skills, both oral and written.Excellent analytical, statistical, and strategic thinking skills.Strong knowledge and skill in the use of MS Office suite; experience with statistical software products (Minitab, SAS, etc.) is preferred.Must be proactive and independent in daily operation.Knowledge of Industrial Quality Control, Quality Engineering, Quality Assurance and Validation, CFRs and their application to Medical Devices or BiopharmaKnowledge of statistical data analysis, word processing, flow charting, and project managementFamiliarity and understanding of manufacturing methods related to the production of medical devices and related productsFamiliarity and understanding of technical disciplines related to Quality Control and Quality Assurance, including Engineering and process controlsGood communication skills, both verbal and writtenAbility to work independently and as a team member, as well as, with Consultants/Contractors to achieve projects' validation objectives What's the environment like? Typically works in an office environment with adequate lighting and ventilation and a normal range of temperature and noise level.Work assignments are diversified. Examples of past precedent are used to resolve work problems. New alternatives may be developed to resolve problems.A frequent volume of work and deadlines impose strain on routine basis.Minimal physical effort is required. Work is mostly sedentary but does require walking, standing, bending, reaching, lifting or carrying objects that typically weigh less than 10 lbs.Although the associate primarily works in an office environment, while performing the duties of this job, the associate is exposed to a production environment. The associate may work near moving mechanical machinery and/or vehicles and the noise level in the work environment can be loud. While performing the duties of this Job, the employee is occasionally exposed to fumes or airborne particles and toxic or caustic chemicals.  skills: Biology, Chemistry Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.EOEDisclaime For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    • san diego, california
    • temporary
    • $24 - $25 per hour
    I have the perfect opportunity for you to work with talented and smart individuals in the bio-tech industry. Want to contribute to empowering women's health all around the world? Ready to earn more and grow in your career? Want to get your foot into a great company? If so, we’re recruiting for research associate roles at Hologic, inc., and it sounds like you might be an ideal fit. This role is an excellent point of entry into one of the top science companies. salary: $24 - $25 per hourshift: Firstwork hours: 6 AM - 6:30 PMeducation: BachelorResponsibilitiesResponsible for assisting scientific staff in carrying out research assignments involving a variety of laboratory methods, equipment and procedures. · Conducts basic laboratory bench experiments. · Participates in analysis and organization of data for presentations. · Writes experimental summaries and technical reports for own data. · Completes paperwork by assigned completion dates. · Carries out assigned laboratory tasks. · Monitor and maintain laboratory notebooks. · Operate lab equipment and perform routine maintenance/repair.The essential functions of this role include:working in a smoke free environmentstanding for 5 hours at one timeworking up to 2 hrs of overtime per weekSkillsJournal EntriesBiotechResearchData EntryWriting - DocumentationLaboratory/SciencesMonth-End CloseGeneral LedgerYear End CloseQualificationsYears of experience: 0 yearsExperience level: Entry LevelRandstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad. Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance. We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    I have the perfect opportunity for you to work with talented and smart individuals in the bio-tech industry. Want to contribute to empowering women's health all around the world? Ready to earn more and grow in your career? Want to get your foot into a great company? If so, we’re recruiting for research associate roles at Hologic, inc., and it sounds like you might be an ideal fit. This role is an excellent point of entry into one of the top science companies. salary: $24 - $25 per hourshift: Firstwork hours: 6 AM - 6:30 PMeducation: BachelorResponsibilitiesResponsible for assisting scientific staff in carrying out research assignments involving a variety of laboratory methods, equipment and procedures. · Conducts basic laboratory bench experiments. · Participates in analysis and organization of data for presentations. · Writes experimental summaries and technical reports for own data. · Completes paperwork by assigned completion dates. · Carries out assigned laboratory tasks. · Monitor and maintain laboratory notebooks. · Operate lab equipment and perform routine maintenance/repair.The essential functions of this role include:working in a smoke free environmentstanding for 5 hours at one timeworking up to 2 hrs of overtime per weekSkillsJournal EntriesBiotechResearchData EntryWriting - DocumentationLaboratory/SciencesMonth-End CloseGeneral LedgerYear End CloseQualificationsYears of experience: 0 yearsExperience level: Entry LevelRandstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad. Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance. We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    • san rafael, california
    • contract
    • $49.38 - $58.09 per hour
    job summary: As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Internationally known for creating cutting-edge biopharmaceuticals for patients who live with rare genetic diseases, our partner strives to develop critical therapies for the small population - mostly children - that suffer from near unheard of conditions. If you're looking for an exciting opportunity to make a difference with an established company, this is the position for you! This role requires employees to be fully vaccinated against COVID-19   location: San Rafael, California job type: Contract salary: $49.38 - 58.09 per hour work hours: 9 to 5 education: Doctorate   responsibilities: Duties: We are seeking a highly motivated Technical Scientist/Scientist who can take a leadership role in moving forward the differentiation and characterization of gene-edited toxiC lines into high quality cardiomyocyte cultures. The successful candidate will be proficient with managing multiple projects and will have extensive iPS CM experience. For the Technical Scientist, the successful candidate will take on a leadership role, providing iPS CM differentiation services for several cardiovascular projects. Takes on a leadership role to conceive strategies, lead the development, evaluation, and implementation of state-of-the-art cell-based disease models to identify novel therapeutic interventions.This exploratory cell biology work will contribute to our understanding of the mechanisms of cardiac disease pathogenesis, and will also provide preclinical proof-of-concept data to guide in the development of novel and safe therapeutics for inherited cardiac diseases with unmet need.Perform cell biology work, publish findings in high-impact journals and present research at major conferences.Effectively partner with the program team, other scientists and the Research and Early Development leadership team to develop and execute on the program's strategic plan.Present program data at a range of internal forums, including Research Seminars and Leadership Team governance forums.Collaborate with various functions, CROs, university or analytical laboratories, business partners, as necessary to ensure appropriate/timely progression of projects.No direct reports associated with this position.  qualifications: Skills: Excellent working cell biology experience in at least one of the following: Functional cardiomyocyte assays, experience with culturing iPS-derived cardiomyocytes, isolation and maintenance of primary cardiac cells, monitoring cardiac cell function with cardio xCELLigence or by high speed calcium imaging, confocal microscopy, high content microscopy, live cell imaging, DNA editing. Excellent written and verbal communication skills Strong analytical skills. Education: A recent Ph.D. with strong experience in cardiovascular research and cardiovascular physiology, pharmacology or a related subject area is required. PhD or equivalent relevant experience plus 0-2+ years industry experience MS with 5+ yearsBS with 8+ years.  skills: Cell Biology Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance. We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    job summary: As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Internationally known for creating cutting-edge biopharmaceuticals for patients who live with rare genetic diseases, our partner strives to develop critical therapies for the small population - mostly children - that suffer from near unheard of conditions. If you're looking for an exciting opportunity to make a difference with an established company, this is the position for you! This role requires employees to be fully vaccinated against COVID-19   location: San Rafael, California job type: Contract salary: $49.38 - 58.09 per hour work hours: 9 to 5 education: Doctorate   responsibilities: Duties: We are seeking a highly motivated Technical Scientist/Scientist who can take a leadership role in moving forward the differentiation and characterization of gene-edited toxiC lines into high quality cardiomyocyte cultures. The successful candidate will be proficient with managing multiple projects and will have extensive iPS CM experience. For the Technical Scientist, the successful candidate will take on a leadership role, providing iPS CM differentiation services for several cardiovascular projects. Takes on a leadership role to conceive strategies, lead the development, evaluation, and implementation of state-of-the-art cell-based disease models to identify novel therapeutic interventions.This exploratory cell biology work will contribute to our understanding of the mechanisms of cardiac disease pathogenesis, and will also provide preclinical proof-of-concept data to guide in the development of novel and safe therapeutics for inherited cardiac diseases with unmet need.Perform cell biology work, publish findings in high-impact journals and present research at major conferences.Effectively partner with the program team, other scientists and the Research and Early Development leadership team to develop and execute on the program's strategic plan.Present program data at a range of internal forums, including Research Seminars and Leadership Team governance forums.Collaborate with various functions, CROs, university or analytical laboratories, business partners, as necessary to ensure appropriate/timely progression of projects.No direct reports associated with this position.  qualifications: Skills: Excellent working cell biology experience in at least one of the following: Functional cardiomyocyte assays, experience with culturing iPS-derived cardiomyocytes, isolation and maintenance of primary cardiac cells, monitoring cardiac cell function with cardio xCELLigence or by high speed calcium imaging, confocal microscopy, high content microscopy, live cell imaging, DNA editing. Excellent written and verbal communication skills Strong analytical skills. Education: A recent Ph.D. with strong experience in cardiovascular research and cardiovascular physiology, pharmacology or a related subject area is required. PhD or equivalent relevant experience plus 0-2+ years industry experience MS with 5+ yearsBS with 8+ years.  skills: Cell Biology Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance. We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    • irvine, california
    • permanent
    • $47,000 - $64,000 per year
    job summary: Exciting opportunity to join a pharmaceutical company as a QA Specialist with an opportunity to grow!   location: Irvine, California job type: Permanent salary: $47,000 - 64,000 per year work hours: 7 to 3 education: Associate   responsibilities: Comply with cGMP regulations and all standard operating procedures.Assist in ensuring all personnel comply with cGMP regulations and follow all standard operating procedures. Provide cGMP guidance as needed.Coordinate and organize internal training program to ensure personnel performing GMP activities are trained per internal SOP.Perform timely review of GMP records (Batch Records, Laboratory Records, Notebooks, etc.). Work closely with QA management to proactively address the quality of documentation. Review and release components, raw materials and finished products.Create, revise and/or review SOPs, protocols, reports, change controls and other GMP documentation.Conduct and/or review complaint, non-conformance, and deviation investigations.Support and organize stability studies for finished product. Provide assist in preparation and during internal, customer and agency audits.Maintain assigned Quality Systems or processes as assigned. Perform tracking and presenting of quality metrics (KPIs). Work with QA management on continuous improvement of the Quality Systems to ensure compliance with regulatory guidelines.Use of electronic QMS and other software as required.Other related duties as assigned.  qualifications: Bachelor's degree in a scientific discipline or equivalent (4 years experience) in a quality control or quality assurance function associated with manufacturing.2+ years experience in quality control or quality assurance function associated with manufacturing preferred.Experience and knowledgeable of cGMP regulations (21 CFR 210/211) preferred.Ability to read and interpret technical procedures, SOP's, GMP's and governmental regulationsStrong communication skills, both written and verbal. Ability to multi-task and prioritize tasks as neededProficient in Microsoft Word, Excel and PowerPoint.  skills: SOP, Quality Assurance, GMP (Good Manufacturing Practice) Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.EOEDisclaime For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    job summary: Exciting opportunity to join a pharmaceutical company as a QA Specialist with an opportunity to grow!   location: Irvine, California job type: Permanent salary: $47,000 - 64,000 per year work hours: 7 to 3 education: Associate   responsibilities: Comply with cGMP regulations and all standard operating procedures.Assist in ensuring all personnel comply with cGMP regulations and follow all standard operating procedures. Provide cGMP guidance as needed.Coordinate and organize internal training program to ensure personnel performing GMP activities are trained per internal SOP.Perform timely review of GMP records (Batch Records, Laboratory Records, Notebooks, etc.). Work closely with QA management to proactively address the quality of documentation. Review and release components, raw materials and finished products.Create, revise and/or review SOPs, protocols, reports, change controls and other GMP documentation.Conduct and/or review complaint, non-conformance, and deviation investigations.Support and organize stability studies for finished product. Provide assist in preparation and during internal, customer and agency audits.Maintain assigned Quality Systems or processes as assigned. Perform tracking and presenting of quality metrics (KPIs). Work with QA management on continuous improvement of the Quality Systems to ensure compliance with regulatory guidelines.Use of electronic QMS and other software as required.Other related duties as assigned.  qualifications: Bachelor's degree in a scientific discipline or equivalent (4 years experience) in a quality control or quality assurance function associated with manufacturing.2+ years experience in quality control or quality assurance function associated with manufacturing preferred.Experience and knowledgeable of cGMP regulations (21 CFR 210/211) preferred.Ability to read and interpret technical procedures, SOP's, GMP's and governmental regulationsStrong communication skills, both written and verbal. Ability to multi-task and prioritize tasks as neededProficient in Microsoft Word, Excel and PowerPoint.  skills: SOP, Quality Assurance, GMP (Good Manufacturing Practice) Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.EOEDisclaime For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    • los angeles, california
    • contract
    • $25.83 - $30.39 per hour
    job summary: As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Our partner recognizes the need for innovative care and utilizes Research & Development to further knowledge in Oncology, Neuroscience, Rare Diseases, and Gastroenterology. As a company that brings in over $30 billion in annual revenue, they have established themselves as a biopharmaceutical powerhouse that is changing the world. If you're looking for a position where your work will benefit millions of people, we are waiting for you!   location: Los Angeles, California job type: Contract salary: $25.83 - 30.39 per hour work hours: 3 to 11 education: Bachelors   responsibilities: This role requires employees to be fully vaccinated against COVID-19 as a condition of employment, subject to a valid medical or religious accommodation. Perform environmental monitoring of clean rooms and controlled areas to support qualifications and routine sampling of the facility and critical utilities including WFI, compressed gas, nitrogen, etc. Conduct microbial-based assays including bioburden testing, microbial quantification, and organism identification. Additional testing includes LAL, pH, TOC, and Conductivity.Perform review of test data with application of GDP.Will be required to perform change requests (e.g. ECR, DCR) when required and complete them in a timely manner. Assure SOPs are updated; prepare and update as determined.Identification and issuance of Alert/OOL forms for out of limit results. May be required to conduct investigations into Alert/OOL excursions.Investigate deviations and write exception documents as required, utilizing problem-solving tools as needed.Support execution of validations for lab equipment, lab methods, or facility projects.May be required to generate, execute, and summarize special laboratory studies.  qualifications: Good project management skills a plus.  skills: Laboratory Information Management Systems (LIMS), GMP (Good Manufacturing Practice) Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance. We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    job summary: As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Our partner recognizes the need for innovative care and utilizes Research & Development to further knowledge in Oncology, Neuroscience, Rare Diseases, and Gastroenterology. As a company that brings in over $30 billion in annual revenue, they have established themselves as a biopharmaceutical powerhouse that is changing the world. If you're looking for a position where your work will benefit millions of people, we are waiting for you!   location: Los Angeles, California job type: Contract salary: $25.83 - 30.39 per hour work hours: 3 to 11 education: Bachelors   responsibilities: This role requires employees to be fully vaccinated against COVID-19 as a condition of employment, subject to a valid medical or religious accommodation. Perform environmental monitoring of clean rooms and controlled areas to support qualifications and routine sampling of the facility and critical utilities including WFI, compressed gas, nitrogen, etc. Conduct microbial-based assays including bioburden testing, microbial quantification, and organism identification. Additional testing includes LAL, pH, TOC, and Conductivity.Perform review of test data with application of GDP.Will be required to perform change requests (e.g. ECR, DCR) when required and complete them in a timely manner. Assure SOPs are updated; prepare and update as determined.Identification and issuance of Alert/OOL forms for out of limit results. May be required to conduct investigations into Alert/OOL excursions.Investigate deviations and write exception documents as required, utilizing problem-solving tools as needed.Support execution of validations for lab equipment, lab methods, or facility projects.May be required to generate, execute, and summarize special laboratory studies.  qualifications: Good project management skills a plus.  skills: Laboratory Information Management Systems (LIMS), GMP (Good Manufacturing Practice) Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance. We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    • south san francisco, california
    • contract
    • $35 - $41.77 per hour
    job summary: As the world's largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. A current top partnership with a research-driven biopharmaceutical company is known as a powerhouse that aims to develop treatments for difficult-to-cure diseases. This renowned employer has created 32 products, including Humira and Lupron, that have highly impacted lives across the globe. If you're looking to stand out in your field and lead the way to innovative therapies, this position is for you! This role requires employees to be fully vaccinated against COVID-19 as a condition of employment, subject to a valid medical or religious accommodation.   location: South San Francisco, California job type: Contract salary: $35.00 - 41.77 per hour work hours: 9 to 5 education: Bachelors   responsibilities: Execute routine purification development operations from harvest to UF/DF operationsPrepare small to large batches of buffer solutions following batch record recipeSupport pilot plant activities including preparation and executionPerform routine analytical measurements using HPLC and UV-vis instrumentationRecord and manage multiple data sets in notebooks and excel filesPerform general lab maintenance including cleanliness and maintaining inventoryCollaborate within the team in order to follow best practices and meet project goalsMust be flexible to participate in innovative projects with shifting priorities and ambiguity in directionMust have a positive can do attitude and be able to research and generate new ideasMust be comfortable with physical activities of constant standing, walking, sitting and occasionally lifting up to 35 lbsProvide verbal updates and presentations at group meetingsGreat interpersonal and communication skills  qualifications: MS in Biochemistry, Chemistry, Chemical/Biochemical Engineering, or related field with 0-3 years of industry experience, or a Bachelor's degree in the above fields with 2 or more years of related experience in: (i) purification technologies/downstream process development (ii) operating chromatography systems, preferably AKTA systems; (iii) experience with analytical assays preferred, such as HPLC and UV-visExperience with Microsoft Office (Word, Excel, PowerPoint)  skills: HPLC, MS-WORD, MS-EXCEL, MS-Powerpoint, Chemistry, GLP (Good Laboratory Practice), GMP (Good Manufacturing Practice) Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance. We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    job summary: As the world's largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. A current top partnership with a research-driven biopharmaceutical company is known as a powerhouse that aims to develop treatments for difficult-to-cure diseases. This renowned employer has created 32 products, including Humira and Lupron, that have highly impacted lives across the globe. If you're looking to stand out in your field and lead the way to innovative therapies, this position is for you! This role requires employees to be fully vaccinated against COVID-19 as a condition of employment, subject to a valid medical or religious accommodation.   location: South San Francisco, California job type: Contract salary: $35.00 - 41.77 per hour work hours: 9 to 5 education: Bachelors   responsibilities: Execute routine purification development operations from harvest to UF/DF operationsPrepare small to large batches of buffer solutions following batch record recipeSupport pilot plant activities including preparation and executionPerform routine analytical measurements using HPLC and UV-vis instrumentationRecord and manage multiple data sets in notebooks and excel filesPerform general lab maintenance including cleanliness and maintaining inventoryCollaborate within the team in order to follow best practices and meet project goalsMust be flexible to participate in innovative projects with shifting priorities and ambiguity in directionMust have a positive can do attitude and be able to research and generate new ideasMust be comfortable with physical activities of constant standing, walking, sitting and occasionally lifting up to 35 lbsProvide verbal updates and presentations at group meetingsGreat interpersonal and communication skills  qualifications: MS in Biochemistry, Chemistry, Chemical/Biochemical Engineering, or related field with 0-3 years of industry experience, or a Bachelor's degree in the above fields with 2 or more years of related experience in: (i) purification technologies/downstream process development (ii) operating chromatography systems, preferably AKTA systems; (iii) experience with analytical assays preferred, such as HPLC and UV-visExperience with Microsoft Office (Word, Excel, PowerPoint)  skills: HPLC, MS-WORD, MS-EXCEL, MS-Powerpoint, Chemistry, GLP (Good Laboratory Practice), GMP (Good Manufacturing Practice) Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance. We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    • san mateo, california
    • permanent
    • $110,000 - $135,000 per year
    job summary: The Clinical Lab Scientist (CLS) will be responsible for the day-to-day operations of the lab. CLSs will be working closely with Clinical Lab Assistants (CLAs) and Supervisor to make sure production goals (e.g., Timeliness and Accuracy of Analysis Report) are met. This role is fundamental to our patient service delivery and plays an integral role in providing a best-in-class patient experience. The CLS will ensure that all case samples are processed and accounted for daily.   location: San Mateo, California job type: Permanent salary: $110,000 - 135,000 per year work hours: 9 to 5 education: Bachelors   responsibilities: Perform accurate testing while maintaining departmental expectations.Follows GLP (Good Laboratory Practice); reports any non-conformity of SOPs to SupervisorEnsures tests are being completed according to approved proceduresAssist the Supervisor in completing projects assignedTrain new hires with the current lab processes and procedures and assists the Supervisor in SOP implementation.Assist the Supervisor in completing staff's competency testingEscalate, classify, and prioritize results issues to SupervisorMaintain best in class client experience standards for the companyShould understand the entire lab process and basic troubleshooting when errors occur.  qualifications: Bachelor's (BA / BS) degree or equivalent in Biological Sciences or related fieldCurrent ASCP board certification in Medical Laboratory Science and California State License for Clinical Laboratory Scientist (CLS) provided by CDPH1 to 3 years of experience in a CLIA lab environment preferredExtremely strong organizational skills and attention to detail.Excellent written and verbal communication skillsA proven track record of issue spotting and escalating issues as necessaryDemonstrated track record of successes in getting things on time  skills: Cell Biology, Biology, GLP (Good Laboratory Practice), Sample Preparation, Sample Testing Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.EOEDisclaime For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    job summary: The Clinical Lab Scientist (CLS) will be responsible for the day-to-day operations of the lab. CLSs will be working closely with Clinical Lab Assistants (CLAs) and Supervisor to make sure production goals (e.g., Timeliness and Accuracy of Analysis Report) are met. This role is fundamental to our patient service delivery and plays an integral role in providing a best-in-class patient experience. The CLS will ensure that all case samples are processed and accounted for daily.   location: San Mateo, California job type: Permanent salary: $110,000 - 135,000 per year work hours: 9 to 5 education: Bachelors   responsibilities: Perform accurate testing while maintaining departmental expectations.Follows GLP (Good Laboratory Practice); reports any non-conformity of SOPs to SupervisorEnsures tests are being completed according to approved proceduresAssist the Supervisor in completing projects assignedTrain new hires with the current lab processes and procedures and assists the Supervisor in SOP implementation.Assist the Supervisor in completing staff's competency testingEscalate, classify, and prioritize results issues to SupervisorMaintain best in class client experience standards for the companyShould understand the entire lab process and basic troubleshooting when errors occur.  qualifications: Bachelor's (BA / BS) degree or equivalent in Biological Sciences or related fieldCurrent ASCP board certification in Medical Laboratory Science and California State License for Clinical Laboratory Scientist (CLS) provided by CDPH1 to 3 years of experience in a CLIA lab environment preferredExtremely strong organizational skills and attention to detail.Excellent written and verbal communication skillsA proven track record of issue spotting and escalating issues as necessaryDemonstrated track record of successes in getting things on time  skills: Cell Biology, Biology, GLP (Good Laboratory Practice), Sample Preparation, Sample Testing Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.EOEDisclaime For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    • san mateo, california
    • permanent
    • $55,000 - $75,000 per year
    job summary: The Clinical Lab Assistant (CLA) will be responsible for assisting in the day-to-day operations of the lab (i.e. Accessioning, Preparation and Analysis of Samples). CLAs will be working closely with Clinical Lab Scientists and Supervisor to make sure production goals (e.g., Accuracy of Analysis Report) are met. This role is fundamental to our patient service delivery and plays an integral role in providing a best-in-class patient experience. Daily, the CLA will verify the proper specimen being analyzed for patients and perform the correct tests that need to be completed. Additionally, the CLA should understand the entire lab process and identify issues when they arise.   location: San Mateo, California job type: Permanent salary: $55,000 - 75,000 per year work hours: 9 to 5 education: Bachelors   responsibilities: Assists the team in day-to-day lab operations according to standard operating proceduresFollows GLP (Good Laboratory Practice); reports any non-conformity of SOPs to SupervisorEnsures production work is consistently completed in a timely manner and accounted forEscalate, classify, and prioritize results issues to SupervisorMaintain best in class client experience standards  qualifications: Bachelor's (BA / BS) degree or equivalent in Biological Sciences or related field1 to 3 years of experience in a CLIA lab environment preferredExtremely strong organizational skills and attention to detail.Excellent written and verbal communication skillsA proven track record of issue spotting and escalating issues as necessaryDemonstrated track record of successes in getting things on time  skills: Cell Biology, Biology, GLP (Good Laboratory Practice), Microbiology, Sample Preparation, Sample Testing Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.EOEDisclaime For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    job summary: The Clinical Lab Assistant (CLA) will be responsible for assisting in the day-to-day operations of the lab (i.e. Accessioning, Preparation and Analysis of Samples). CLAs will be working closely with Clinical Lab Scientists and Supervisor to make sure production goals (e.g., Accuracy of Analysis Report) are met. This role is fundamental to our patient service delivery and plays an integral role in providing a best-in-class patient experience. Daily, the CLA will verify the proper specimen being analyzed for patients and perform the correct tests that need to be completed. Additionally, the CLA should understand the entire lab process and identify issues when they arise.   location: San Mateo, California job type: Permanent salary: $55,000 - 75,000 per year work hours: 9 to 5 education: Bachelors   responsibilities: Assists the team in day-to-day lab operations according to standard operating proceduresFollows GLP (Good Laboratory Practice); reports any non-conformity of SOPs to SupervisorEnsures production work is consistently completed in a timely manner and accounted forEscalate, classify, and prioritize results issues to SupervisorMaintain best in class client experience standards  qualifications: Bachelor's (BA / BS) degree or equivalent in Biological Sciences or related field1 to 3 years of experience in a CLIA lab environment preferredExtremely strong organizational skills and attention to detail.Excellent written and verbal communication skillsA proven track record of issue spotting and escalating issues as necessaryDemonstrated track record of successes in getting things on time  skills: Cell Biology, Biology, GLP (Good Laboratory Practice), Microbiology, Sample Preparation, Sample Testing Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.EOEDisclaime For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
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