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14 jobs found in los angeles, california

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    • 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 (BS) in Biochemistry, Chemistry, Molecular and Cell biology, or Biology required. Masters degree preferred. In lieu of this requirement, work experience may be considered3-5 years' flow cytometry 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, Flow Cytometry, 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 (BS) in Biochemistry, Chemistry, Molecular and Cell biology, or Biology required. Masters degree preferred. In lieu of this requirement, work experience may be considered3-5 years' flow cytometry 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, Flow Cytometry, 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.
    • 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 disciplineProven 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: Biology, Food Product Development 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 disciplineProven 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: Biology, Food Product Development 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
    • 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.
    • 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.
    • buena park, california
    • permanent
    • $100,000 per year
    job summary: In partnership with Amway, we are conducting a direct hire search for a Sensory and Consumer Research Scientist! Amway is a $9B Global Leader in Nutrition and Wellness. This role is part of the team at their Nutrilite Center of Excellence in Buena Park, CA. Enjoy a hybrid schedule and 3-day weekends! This team works four 10-hour days M-Th.   location: Buena Park, California job type: Permanent work hours: 8 to 4 education: Bachelors   responsibilities: In this role, you will design and execute sensory and consumer research for nutrition products (including supplements, food and beverage) to serve both adult and child consumers. You will identify and interpret customer needs and insights to enable the team to make consumer-focused decisions.   qualifications: BS Degree in Food Science, Nutrition, or a related discipline with sensory science focus3 years' experience in nutrition or food sensory research and consumer product researchDemonstrated experience leading sensory and consumer research (experience working with children preferred) including designing experiments, gathering, analyzing, and translating data into meaningful recommendationsExperience overseeing the design and execution of various consumer product tests (ie. central location tests, descriptive analysis, discrimination testing, and qualitative/observational methodologies, etc)Statistical experimental design and analysis skills for interpreting complex data and translating into business support materialsExperience as active contributor on food/nutrition product development teamsExperience in Human Centered Design preferred  skills: Sensory Analysis 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: In partnership with Amway, we are conducting a direct hire search for a Sensory and Consumer Research Scientist! Amway is a $9B Global Leader in Nutrition and Wellness. This role is part of the team at their Nutrilite Center of Excellence in Buena Park, CA. Enjoy a hybrid schedule and 3-day weekends! This team works four 10-hour days M-Th.   location: Buena Park, California job type: Permanent work hours: 8 to 4 education: Bachelors   responsibilities: In this role, you will design and execute sensory and consumer research for nutrition products (including supplements, food and beverage) to serve both adult and child consumers. You will identify and interpret customer needs and insights to enable the team to make consumer-focused decisions.   qualifications: BS Degree in Food Science, Nutrition, or a related discipline with sensory science focus3 years' experience in nutrition or food sensory research and consumer product researchDemonstrated experience leading sensory and consumer research (experience working with children preferred) including designing experiments, gathering, analyzing, and translating data into meaningful recommendationsExperience overseeing the design and execution of various consumer product tests (ie. central location tests, descriptive analysis, discrimination testing, and qualitative/observational methodologies, etc)Statistical experimental design and analysis skills for interpreting complex data and translating into business support materialsExperience as active contributor on food/nutrition product development teamsExperience in Human Centered Design preferred  skills: Sensory Analysis 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.
    • pasadena, california
    • contract
    • $35 - $40 per hour
    job summary: The Associate Scientist, Cell Manufacturing and Process Development will perform a broad range of tasks associated with the manufacture of cells for use in clinical and developmental studies. This resource will work as part of the team to execute Process Development Activities, plan and execute laboratory studies in order to support process development, characterization or process improvements   location: Pasadena, California job type: Contract salary: $35 - 40 per hour work hours: 9 to 5 education: Bachelors   responsibilities: Adheres to laboratory quality systems, batch records, SOPs, and cGMP regulations. Accurately completes documentation associated with development activities and sample analysis and records experiments in electronic lab notebook.Develops and executes protocols related to cell culture, processing and other activities as neededAssist with Technical Transfer of methods and procedures to the Cell Manufacturing departmentPerform analytical assays (ddPCR, CFU assay, Flow cytometry) to assist with Process developmentDrafts and reviews Standard Operating Procedures (SOPs), Batch Records, technical reports, and other documents for processes, equipment and test assays.Assists with testing and evaluation of new Equipment and commissioning.Assists with routine maintenance of scientific instrumentation, and equipment as required.Maintains current training status for all applicable activities.Provides feedback to Lead Scientist and ManagerPresents experimental data at departmental or project meetingsWorks well in a team environment, collaborates well with various colleagues in other groups such as Bioanalytics, QA and OperationsEnsures high safety standards are adhered to as governed by local, state and federal regulations, laws and policies   qualifications: Bachelor's degree (BS) or Master's degree (MS) Life Sciences (Cellular Biology, Immunology, or Biomedical)Familiarity with GMP manufacturing processes and working within a controlled environment2+ years' experience in cell /gene therapy processing, familiarity with HSC is a plusExperience with analytical methods to characterize in process and final cell product samples (gene marking, CFU assay, flow cytometry)At least three years laboratory experience in biomedical research or a clinical laboratory with an emphasis on GMP practices, validation and execution of Laboratory SOPs and QC/QA practices.Experience in cell enrichment, culture, and cryopreservation of human HSPCs Preferred Skills / Experience: Three (3) years laboratory experience in biomedical research or a clinical laboratory with experience in Cellular Biology, Immunology, Hematology and/or Hematopoietic Stem and Progenitor Cell Biology (HSPC) preferred.   skills: Cell Biology, PCR, Flow Cytometry, 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.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 Associate Scientist, Cell Manufacturing and Process Development will perform a broad range of tasks associated with the manufacture of cells for use in clinical and developmental studies. This resource will work as part of the team to execute Process Development Activities, plan and execute laboratory studies in order to support process development, characterization or process improvements   location: Pasadena, California job type: Contract salary: $35 - 40 per hour work hours: 9 to 5 education: Bachelors   responsibilities: Adheres to laboratory quality systems, batch records, SOPs, and cGMP regulations. Accurately completes documentation associated with development activities and sample analysis and records experiments in electronic lab notebook.Develops and executes protocols related to cell culture, processing and other activities as neededAssist with Technical Transfer of methods and procedures to the Cell Manufacturing departmentPerform analytical assays (ddPCR, CFU assay, Flow cytometry) to assist with Process developmentDrafts and reviews Standard Operating Procedures (SOPs), Batch Records, technical reports, and other documents for processes, equipment and test assays.Assists with testing and evaluation of new Equipment and commissioning.Assists with routine maintenance of scientific instrumentation, and equipment as required.Maintains current training status for all applicable activities.Provides feedback to Lead Scientist and ManagerPresents experimental data at departmental or project meetingsWorks well in a team environment, collaborates well with various colleagues in other groups such as Bioanalytics, QA and OperationsEnsures high safety standards are adhered to as governed by local, state and federal regulations, laws and policies   qualifications: Bachelor's degree (BS) or Master's degree (MS) Life Sciences (Cellular Biology, Immunology, or Biomedical)Familiarity with GMP manufacturing processes and working within a controlled environment2+ years' experience in cell /gene therapy processing, familiarity with HSC is a plusExperience with analytical methods to characterize in process and final cell product samples (gene marking, CFU assay, flow cytometry)At least three years laboratory experience in biomedical research or a clinical laboratory with an emphasis on GMP practices, validation and execution of Laboratory SOPs and QC/QA practices.Experience in cell enrichment, culture, and cryopreservation of human HSPCs Preferred Skills / Experience: Three (3) years laboratory experience in biomedical research or a clinical laboratory with experience in Cellular Biology, Immunology, Hematology and/or Hematopoietic Stem and Progenitor Cell Biology (HSPC) preferred.   skills: Cell Biology, PCR, Flow Cytometry, 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.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.

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