AstraZeneca
Associate Director, Process Development, Cell Therapy
$138K–$207K
US – Santa Monica Colorado Avenue – CA · Director · Full-time · Posted Oct 30, 2026
- Experience
- Ph.D.: 6+ years of industry experience; M.S.: 10+ years of relevant experience; B.S.: 12+ years of relevant experience.
- Education
- Ph.D. in Chemical Engineering, Biochemical Engineering, Biological Sciences, Biotechnology, Pharmaceutical Sciences, or related discipline; or M.S.; or B.S.
About the job
Leads late-stage cell therapy process development, commercialization readiness, and lifecycle management, including team leadership, manufacturing support, technology transfer, and regulatory submissions.
What you'll do
- Lead process development projects and teams; oversee study execution, technical documentation, risk assessment, and data analysis.
- Support PPQ, technology transfer, commercial process lifecycle management, and manufacturing investigations and improvements.
- Contribute to CMC documentation and BLA/MAA submissions; apply AI-enabled tools and digital analytics to process data and workflows.
What they ask for
- Strong technical expertise in cell therapy process development, GMP operations, and late-stage or commercial readiness.
- Experience with late-stage development and PPQ for cell therapy processes.
- Proficiency applying AI tools and digital solutions to data analysis, documentation, and workflow automation.
- Strong technical writing, data analysis, and problem-solving skills.
Nice to have
- Experience with commercial-stage cell therapy or biologics products; supporting PPQ, process validation, and post-approval changes.
- Familiarity with global regulatory requirements and lifecycle management strategies; experience designing and executing DOE and multivariate data analysis for cell therapy processes.
Pay
USD 138K to USD 207K annual base pay
Tools
AI tools, digital solutions, DOE
AI focus
Apply AI tools and digital solutions to data analysis, documentation, workflow automation, data review, trend analysis, batch record evaluation, and process understanding.
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