associate scientist, cell manufacturing & process development.

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: 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 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.