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

AstraZeneca•Gaithersburg, MD

5d•$146,722 - $220,082•Onsite

About The Position

AstraZeneca is seeking an experienced principal process engineer for our cell therapy Global Manufacturing Science and Technology (MS&T) team. This position is responsible for 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, defining process validation strategy, driving implementation of continuous process improvements, and authoring validation and regulatory deliverables to enable commercialization and lifecycle management across a global network of AstraZeneca’s manufacturing sites.

Requirements

Education: B.S or 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 4+ years; OR M.S. with 8+ years, OR B.S. with 10+ 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.
Extensive background in GMP manufacturing operations and technology transfer.
Experience in process validation and CPV.
Experience in authoring and defending 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.

Responsibilities

Development and Manufacturing Interface: Represent Global MSAT in the technology transfer and process characterization teams to ensure successful commercialization of cell therapy products.
Represent Manufacturing Operations on product CMC teams, and ensure high-quality and timely program deliverables (clinical & commercial supply, site approvals).
Develop PPQ readiness and PPQ execution technical framework for the site MSAT team and oversee execution at the manufacturing sites.
Develop 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.
Manage post-approval process optimization initiatives, comparability strategies, ensuring scientific rigor and managing regulatory risks.
Proactively identify and mitigate technical and operational risks; drive lessons-learned cycles and standardization across sites and teams.
Regulatory & Quality Support: Lead global Change Controls and ensure timely implementation and compliance.
Author 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: You will work in close partnership with Late-Stage Process Development — Ensure process definition, improvements, and process characterization reflect lifecycle strategy.
Site MS&T — partner to ensure timely implementation of process changes and improvements at the sites.
Quality — ensure process compliance and product quality standards.
CMC Regulatory — align on submission strategy and regulatory positioning.
Supply Chain — inform long-range supply planning and risk mitigation.
CMC Leadership — provide MSAT input for late-stage development and commercial readiness.