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

AstraZeneca•Gaithersburg, MD

2d•$216,996 - $325,494

About The Position

AstraZeneca is seeking a Senior Director of Manufacturing Science and Technology (MSAT) to serve as a senior-technical leader for the Cell Therapy manufacturing sites across a global network of AstraZeneca. You will be responsible for receiving manufacturing processes at the sites and supporting clinical manufacture, process validation, and commercial manufacture at AstraZeneca’s internal manufacturing sites, partnering closely with Manufacturing Operations, Quality, Supply Chain, and QC Operations teams located at the manufacturing sites. This is a leadership position responsible for developing and managing MSAT teams located at the manufacturing sites. Your group will own the cell therapy manufacturing support for the sites — from tech transfer of the clinical manufacturing process to process validation, commercial manufacture, and post-approval process improvements specific to manufacturing sites — partnering 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. Advanced degree preferred.
12+ years of progressive experience for cell therapy/biologics/vaccines modalities in technical development, manufacturing operation, CMC leadership or CMO management areas.
Technical expertise in cell therapy manufacturing processes and technologies is highly desirable. Experience in the biologics or viral vectors or vaccines will be considered.
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.

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 a 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 that includes 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 across all manufacturing sites.
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 products.
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 INDa, BLA, MAA, and supplements — reviewing CMC sections to ensure alignment with the 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 global MSAT team.
Work in close partnership with Manufacturing Operations – align with site capability and readiness and provide routine support to enable flowless execution at the site.
Work in close partnership with Quality — ensuring process compliance and product quality standards at the site.
Work in close partnership with Supply Chain — align and support readiness for supply of the clinical and commercial products.
Work in close partnership with CMC Leadership — providing site MSAT input for tech transfer, clinical manufacture, process validation and commercial supply.
Participate in Change Controls and Technical Governance Committees.