Senior Process Engineer, Global Manufacturing Science and Technology, Cell Therapy Technical Operations

AstraZeneca is seeking an experienced senior process engineer for our cell therapy Global Manufacturing Science and Technology (MS&T) team. This position is responsible for supporting the technical oversight of robust, compliant, and cost-effective end-to-end cell therapy manufacturing processes.

Responsibilities

• Development and Manufacturing Interface
  • Represent Global MSAT in the technology transfer and process characterization teams to ensure successful commercialization of cell therapy products.
  • Communicate Manufacturing Operations needs to the CMC team, and ensure high-quality and timely program deliverables (comparability and validation study completion, etc).
  • Develop PPQ readiness and PPQ execution technical framework for the site MSAT team and oversee execution at the manufacturing sites.
  • Implement proactive process analysis and Continued Process Verification (CPV) strategies across manufacturing sites to ensure continued process understanding and process control across all manufacturing sites.
• Lifecycle Management
  • Provide technical oversight across cell therapy manufacturing lifecycle — from pivotal manufacturing technology transfer, process validation, commercialization, and post-approval.
  • Identify and implement process improvements that increase process robustness, cost of goods, plant throughput, and supply continuity.
  • Contribute to post-approval process optimization initiatives, comparability strategies, ensuring scientific rigor and managing regulatory risks.
  • Proactively identify and mitigate technical and operational risks; ensure standardization across sites and teams.
• Regulatory & Quality Support
  • Lead global Change Controls and ensure timely implementation and compliance.
  • Contribute to authoring CMC sections of regulatory submissions — Pivotal INDa, BLA, MAA, and supplements — with high efficiency and optimal content.
  • Partner with quality and regulatory to maintain full compliance with cGMP, ICH guidelines, and global regulatory expectations.
  • Develop and defend sound scientific justifications for the integrated control strategy and lifecycle changes.
• Cross-Functional Partnerships
  • Work in close partnership with Late-Stage Process Development — provide MSAT input for process definition, improvements, and process characterization.
  • Partner with Site MS&T to ensure timely implementation of process changes and improvements at the sites.
  • Ensure process compliance and product quality standards with Quality teams.
  • Inform long-range supply planning and risk mitigation with Supply Chain.

Requirements

• Education: B.S, M.S., or Ph.D. in Chemical/Biochemical/Biomedical Engineering, Bioengineering, Biochemistry, Biotechnology, Cell Biology, or a closely related discipline. Advanced degree preferred.
• Experience:
  • Ph.D. with 1+ years; OR M.S. with 5+ years, OR B.S. with 7+ years of relevant cell therapy/biologics/vaccines industry experience in technical development, MS&T, or CMO management areas.
  • Technical and hands-on expertise in cell therapy manufacturing processes and technologies is highly desirable. Experience in viral vectors, vaccines, or biologics will be considered.
  • Background in GMP manufacturing operations and technology transfer.
  • Experience in process validation and CPV desired.
  • Experience in authoring CMC sections for major regulatory filings (INDa, BLA, MAA) and regulatory inspections.
  • High standards of quality, accountability, and urgency — with the resilience to thrive in a fast-paced cell & gene therapy field.

Pay

The annual base pay for this position ranges from $96,196.80 - $144,295.20. Positions offer eligibility for various incentives—short-term incentive bonuses, equity-based awards for salaried roles, and commissions for sales roles.

Benefits

• Qualified retirement programs.
• Paid time off (vacation, holiday, and leaves).
• Health, dental, and vision coverage in accordance with the terms of the applicable plans.

This role requires up to 10% domestic and international travel.