Associate Process Engineer, Cell Therapy Process Development

AstraZeneca • Santa Monica, CA

1d • $67,000 - $101,000

About The Position

We are seeking a highly motivated Associate Process Engineer to support late-stage cell therapy process development and characterization activities. The role supports advancement of late-stage process development, process characterization, and BLA-enabling studies, with a focus on cell therapy unit operations including T-cell enrichment, activation, transduction, washes, and harvest using semi-automated or fully automated equipment. The position requires technical expertise and hands-on experience with cell therapy unit operations, as well as success supporting clinical and commercial readiness.

Requirements

• Bachelor of Science 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.
• Ability to analyze complex datasets, develop sound recommendations, and communicate clearly across levels.
• Experience with late-stage development and process characterization principles for cell therapy processes.
• 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

• Familiarity with automation platforms such as CliniMACS Prodigy, Lovo, G-Rex, and 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.

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