Senior Process Engineer, Cell Therapy Process Development

AstraZeneca seeks a Senior Process Engineer to advance late-stage cell therapy process development and commercialization. The role involves process characterization, scale-up support, technology transfer, and regulatory documentation for autologous and allogeneic cell therapies, with emphasis on unit operations automation and GMP compliance.

Responsibilities

• Design and execute cell therapy process optimization, robustness studies, and characterization experiments aligned with QbD and ICH guidelines
• Implement closed-system operations and automation strategies for scalability and compliance
• Contribute to PPQ planning, execution, and documentation; support technology transfer to manufacturing sites
• Author and review CMC documentation including process descriptions, characterization summaries, and control strategy elements for BLA/MAA submissions
• Provide on-site technical support during scale-up, engineering runs, PPQ batches, and commercial manufacturing campaigns

Requirements

• Ph.D. in Chemical, Biochemical, or Biotech Engineering with 2+ years industry experience; or M.S. with 5+ years; or B.S. with 7+ years hands-on experience
• Deep technical expertise in cell therapy unit operations including isolation, activation, transduction, expansion, and harvest
• Demonstrated experience with GMP operations and late-stage commercial readiness
• Proven ability to design and execute process characterization studies, DOE, and scale-down models
• Proficiency with AI tools and digital solutions for data analysis and workflow automation
• Strong technical writing, data analysis, and cross-functional communication skills
• Experience with batch record execution, deviation assessment, and investigation in GMP environments

Compensation: $96,000-$144,000 base