Senior Process Engineer, Global Manufacturing Science and Technology, Cell Therapy Technical Operations
About The Position
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. Activities include leading technology transfer for pivotal clinical manufacturing, process performance monitoring, supporting definition of process validation strategy, leading implementation of continuous process improvements, and contributing to validation and regulatory deliverables to enable commercialization and lifecycle management across a global network of AstraZeneca’s manufacturing sites.
Requirements
- 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.
Nice To Haves
- Advanced degree preferred.
Responsibilities
- 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
- 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
- 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
Benefits
- qualified retirement programs
- paid time off (i.e., vacation, holiday, and leaves)
- health, dental, and vision coverage
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
