Associate Process Engineer, Cell Therapy Process Development

AstraZeneca • Santa Monica, CA

5d

About The Position

We are seeking a highly motivated Associate Process Engineer to support late-stage cell therapy process development and characterization activities, including BLA-enabling studies. The role focuses on cell therapy unit operations such as T-cell enrichment, activation, transduction, washes, and harvest using semi-automated or fully automated equipment. The successful candidate will bring hands-on technical expertise and help advance clinical and commercial readiness.

The position supports development and characterization of autologous or allogeneic cell therapy processes, implementation of closed-system operations and automation, and studies aligned with Quality by Design (QbD) and ICH guidelines. It also involves analyzing and communicating study outcomes, supporting GMP process robustness through batch record review and deviation assessment, and using AI-enabled tools and digital analytics to improve data review and process understanding.

Requirements

• Bachelor’s degree in Chemical Engineering, Biochemical Engineering, Biotechnology, or a related field; alternatively, an associate degree with 2+ years of hands-on industry experience.
• Strong technical expertise in key cell therapy unit operations, such as cell isolation, activation, transduction, expansion, harvest, formulation, and cryopreservation, or in biologics.
• Demonstrated experience with GMP operations and late-stage or commercial readiness.
• Experience with late-stage development and process characterization 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.
• Ability to analyze complex datasets, develop sound recommendations, and communicate clearly across levels.
• Strong technical writing, data analysis, and problem-solving skills.
• Experimental design and execution skills.
• Cross-functional communication and collaboration skills.
• Ability to operate effectively in fast-paced, late-stage development environments.
• Scientific curiosity, an ownership mindset, and willingness to support manufacturing operations.

Nice To Haves

• Familiarity with automation platforms such as CliniMACS Prodigy, Lovo, G-Rex, or 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.
• Formal training or demonstrated application of digitalization, automation, or AI-enabled tools in bioprocess development.

Responsibilities

• Design, execute, and support autologous or allogeneic 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, including DOE, multivariate studies, scale-down models, and scale-up assessments, in alignment with QbD and ICH guidelines.
• Analyze data, write technical reports, and present study outcomes to cross-functional teams and governance forums.
• 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.
• Support manufacturing operations as needed.

Benefits

• Eligibility for short-term incentive bonuses.
• Equity-based awards for salaried roles.
• Qualified retirement programs.
• Paid time off, including vacation, holidays, and leaves.
• Health coverage.
• Dental coverage.
• Vision coverage.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree