Senior Director, Site Manufacturing Science and Technology, Cell Therapy Technical Operations

AstraZeneca•Gaithersburg, MD

22h

About The Position

AstraZeneca is seeking a Senior Director of Manufacturing Science and Technology (MSAT) to serve as a senior technical leader for Cell Therapy manufacturing sites across a global network. This role is responsible for receiving manufacturing processes at the sites and supporting clinical manufacture, process validation, and commercial manufacture at AstraZeneca’s internal manufacturing sites. The position involves close collaboration with Manufacturing Operations, Quality, Supply Chain, and QC Operations teams located at the manufacturing sites. It is a leadership position responsible for developing and managing MSAT teams at the manufacturing sites. The group will own the cell therapy manufacturing support for the sites, encompassing tech transfer of clinical manufacturing processes, process validation, commercial manufacture, and post-approval process improvements specific to manufacturing sites, in partnership with Global Manufacturing Science and Technology and Manufacturing Operations teams.

Requirements

B.S or M.S. or Ph.D. in Chemical/Biochemical/Biomedical Engineering, Bioengineering, Biochemistry, Biotechnology, Cell Biology, or a closely related discipline.
12+ years of progressive experience for cell therapy/biologics/vaccines modalities in technical development, manufacturing operation, CMC leadership or CMO management areas.
Extensive background in GMP manufacturing operations, site readiness for clinical manufacture, process validation, and commercial supply, and site support for commercial products.
Proven record of building, leading, and mentoring high-performing technical and cross-functional teams.

Nice To Haves

Advanced degree preferred.
Technical expertise in cell therapy manufacturing processes and technologies is highly desirable.
Experience in the biologics or viral vectors or vaccines will be considered.

Responsibilities

Define and execute the Site MSAT function strategy aligned with Cell Therapy Technical Operations to enable development and supply objectives across clinical and commercial stages.
Build, mentor, and develop high-performing Site MSAT teams with deep expertise in cell therapy GMP operations and process science and technology.
Serve as a core member of the site Manufacturing Operations team, contributing to long-range supply planning, risk mitigation, and operational excellence.
Lead, develop, and oversee late-stage and commercial process execution strategies at manufacturing sites to enable harmonization and quality and regulatory compliance.
Represent Site MSAT in technology transfer, process validation, and commercial supply teams to ensure successful supply of cell therapy products.
Represent Manufacturing Operations in the CMC team, ensuring high-quality and timely program deliverables (clinical & commercial supply, site approvals).
Lead Clinical manufacture and PPQ readiness at the manufacturing site, including material, facility, equipment, manufacturing systems, documentation, and process operations readiness.
Implement and maintain Proactive Process Analysis (PPA) and Continued Process Verification (CPV) strategies across manufacturing sites to ensure continued process understanding and process control.
Identify and implement process improvements that improve process robustness, cost of goods, plant throughput, and supply continuity within the boundaries of an approved or cleared clinical product.
Proactively identify and mitigate technical and operational risks; drive lessons-learned cycles and standardization across sites and teams.
Serve as the senior accountable Site MSAT leader for regulatory submissions (Pivotal IND, BLA, MAA, and supplements), reviewing CMC sections to ensure alignment with site operations.
Lead site preparedness and technical support for health authority inspections and audits, working closely with Quality and Manufacturing Ops teams.
Partner with quality and regulatory to maintain full compliance with cGMP, ICH guidelines, and global regulatory expectations.
Develop and defend sound scientific justifications for site operations (SOPs, MBRs, Manufacturing systems, Operation trainings), and any site-specific changes to the approved products.
Lead site-specific Change Controls and ensure timely implementation and compliance, working with the global MSAT team.
Work in close partnership with Manufacturing Operations to align with site capability and readiness and provide routine support for flawless execution at the site.
Work in close partnership with Quality to ensure process compliance and product quality standards at the site.
Work in close partnership with Supply Chain to align and support readiness for supply of clinical and commercial products.
Work in close partnership with CMC Leadership to provide site MSAT input for tech transfer, clinical manufacture, process validation, and commercial supply.
Participate in Change Controls and Technical Governance Committees.