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

AstraZeneca•Gaithersburg, MD

4d•Remote

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

B.S or M.S. or Ph.D. in Chemical/Biochemical/Biomedical Engineering, Bioengineering, Biochemistry, Biotechnology, Cell Biology, or a closely related discipline.
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.
Background in GMP manufacturing operations and technology transfer.
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.
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.
Experience in process validation and CPV desired.

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
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 in partnership with Quality
Inform long-range supply planning and risk mitigation in partnership with Supply Chain