Process Engineer, Cell Therapy Process Development

AstraZeneca seeks a process engineer to support late-stage cell therapy development and commercialization. The role focuses on process optimization, characterization studies, scale-up activities, and GMP compliance for autologous and allogeneic cell therapies using semi-automated and fully automated equipment.

Responsibilities

• Design, execute, and support optimization and robustness studies for autologous and allogeneic cell therapy processes
• Develop and implement closed-system operations and automation strategies to support scalability and regulatory compliance
• Plan and execute process characterization studies aligned with QbD and ICH guidelines; analyze data and present findings
• Provide technical support during scale-up, engineering runs, PPQ batches, and commercial manufacturing including off-shift coverage
• Conduct batch record review, deviation assessment, and data trending to ensure manufacturing process robustness

Requirements

• M.S. in Chemical, Biochemical, or Biotechnology Engineering with 2+ years industry experience, or B.S. with 7+ years hands-on experience
• Deep technical expertise in cell therapy unit operations including enrichment, activation, transduction, and harvest
• Demonstrated experience with GMP operations and late-stage commercial readiness
• Proven ability to design and execute process characterization studies using DOE and multivariate analysis
• Proficiency in data analysis, technical writing, and cross-functional communication
• Experience applying AI tools and digital solutions to bioprocess data analysis and workflow automation
• Working knowledge of batch record execution, deviation management, and investigations in GMP environments

Compensation: $81,000–$122,000 base