Senior Process Engineer, Cell Therapy Process Development
AstraZeneca•Santa Monica, CA
•$96,000 - $144,000
About The Position
We are seeking a highly motivated Senior Process Engineer to support cell therapy process characterization and commercialization activities. In this role, you will play critical role in advancing late-stage cell therapy process development, process characterization, PPQ readiness, BLA‑enabling studies, and technology transfer to different manufacturing sites. This position focuses specifically on cell therapy unit operations, including T-cell enrichment, activation, transduction, washes and harvest either semi-automated or automated equipment. The ideal candidate brings deep technical expertise, hands-on experience with cell therapy unit operations, and demonstrates success in supporting clinical and commercial readiness.
Requirements
- Ph.D. in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field with 2+ years of industry experience; OR M.S. with 5+ years; OR B.S. with 7+ years of hands‑on industry experience.
- Strong technical expertise in key cell therapy unit operations (e.g., cell isolation, activation, transduction, expansion, harvest, formulation, cryopreservation).
- Demonstrated experience with GMP operations and late‑stage / commercial readiness.
- Proven ability to analyze complex datasets, develop sound recommendations, and communicate clearly across levels
- Experience with late‑stage development, process characterization, and PPQ principles for cell therapy processes.
- Demonstrated proficiency in applying AI tools and digital solutions to data analysis, documentation, and workflow automation.
- Experience working in GMP environments, including batch record execution or review, deviations, and investigations.
- Strong technical writing, data analysis, and problem‑solving skills.
Nice To Haves
- Experience with viral vector handling (Lentivirus, AAV) in manufacturing processes.
- Familiarity with automation platforms (e.g., CliniMACS Prodigy, Lovo, G-Rex, Wave bioreactors).
- Experience implementing closed, automated, or high‑throughput systems.
- Experience designing and executing DOE and multivariate data analysis for cell therapy processes.
- Experience with JMP or similar statistical analysis tools.
- Experience contributing to BLA/MAA submissions or regulatory interactions.
- Knowledge of control strategy development and risk assessment tools (e.g., FMEA).
- Formal training or demonstrated application of digitalization, automation, or AI‑enabled tools in bioprocess development.
Responsibilities
- Process development and characterization: Design, execute, and support autologous or allogenic cell therapy process optimization and robustness studies.
- Drive implementation of closed-system operations and automation strategies to support scalability and compliance.
- Plan and execute process characterization studies (DOE, multivariate studies, scale‑down models, and scale‑up assessments) in alignment with QbD and ICH guidelines.
- Perform risk assessment, data analysis, write technical reports, and present outcome of the studies to cross‑functional teams and governance forums.
- Support development and refinement of control strategies for cell therapy processes, including raw materials, and cell therapy process parameters.
- Conduct batch record review, deviation assessment, and data trending to ensure robustness of cell therapy manufacturing processes.
- Apply AI‑enabled tools and digital analytics to accelerate data review, trend analysis, batch record evaluation, and process understanding.
- PPQ, Tech Transfer & Manufacturing Readiness: Contribute to PPQ planning, readiness, execution, and documentation for cell therapy processes.
- Support technology transfer of cell therapy processes to internal manufacturing sites including make-a-batch assessments and drafting manufacturing batch record.
- Provide on‑the‑floor technical support during scale‑up, engineering runs, PPQ batches, and commercial manufacturing campaigns (including off‑shift support when required).
- Support raw material risk assessments, comparability studies, and process risk evaluations across facilities and platforms.
- Regulatory Support: Contribute to authoring and reviewing CMC documentation, including cell therapy process descriptions, characterization summaries, PPQ protocols and reports, and control strategy elements.
- Support preparation of BLA/MAA submissions and responses to regulatory questions related to cell therapy manufacturing.
- Cross‑Functional Collaboration: Work closely with analytical sciences, quality, regulatory, and manufacturing teams to ensure end‑to‑end process alignment.
- Represent cell therapy characterization activities in technical meetings, reviews, and governance discussions.
- Support lifecycle management, post‑approval changes, and continuous improvement initiatives for cell therapy processes.
Benefits
- Eligibility for multiple incentives
- Opportunity to receive short-term incentive bonuses
- Equity-based awards for salaried roles
- Qualified retirement programs
- Paid time off (i.e., vacation, holiday, and leaves)
- Health, dental, and vision coverage
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What This Job Offers
Job Type
Full-time
Career Level
Senior
