Process Engineer, Cell Therapy Process Development

AstraZeneca seeks a Process Engineer to support late-stage cell therapy process development and characterization. The role focuses on cell therapy unit operations, process optimization, scale-up activities, and GMP compliance to advance clinical and commercial readiness.

Responsibilities

• Design and execute cell therapy process optimization and robustness studies aligned with QbD and ICH principles
• Lead process characterization activities including DOE, multivariate analysis, and scale-up assessments
• Provide on-the-floor technical support during scale-up, engineering runs, PPQ batches, and manufacturing campaigns
• Conduct batch record review, deviation assessment, and data trending to ensure manufacturing robustness
• Collaborate with analytical and manufacturing science teams on process alignment and lifecycle management

Requirements

• M.S. in Chemical Engineering, Biochemical Engineering, or Biotechnology with 2+ years industry experience, or B.S. with 7+ years
• Expertise in cell therapy unit operations including isolation, activation, transduction, expansion, and harvest
• Experience with GMP operations and late-stage or commercial manufacturing readiness
• Demonstrated ability to analyze complex datasets and communicate technical findings across organizational levels
• Proficiency with AI tools and digital solutions for data analysis and workflow automation
• Experience executing or reviewing batch records, managing deviations, and conducting investigations
• Strong technical writing, data analysis, and problem-solving capabilities

Compensation: $81,000–$122,000 base