MSAT Director, Cell Therapy Manufacturing & Strategy

AstraZeneca GmbH; Gaithersburg (MD); On-site; USD 217,000 - 325,000; Full time

Job summary

AstraZeneca GmbH in Gaithersburg, MD is seeking a Site MSAT Leader to 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.

You will build, mentor, and develop a high-performing Site MSAT team with deep expertise in cell therapy GMP operations and process science and technology, and represent MSAT in technology transfer, process validation, and commercial supply efforts.

Qualifications

• B.S. or M.S. or Ph.D. in Chemical/Biochemical/Biomedical Engineering, Bioengineering, Biochemistry, Biotechnology, Cell Biology, or closely related discipline. Advanced degree preferred.
• 12+ years of progressive experience in cell therapy/biologics/vaccines across development and manufacturing operations.
• Extensive GMP manufacturing operations and site readiness experience.
• Proven track 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 Clinical manufacture and PPQ readiness at the manufacturing site that includes material, facility, equipment, manufacturing systems, documentation and process operations readiness.
• 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 site-specific Change Controls and ensure timely implementation and compliance working with global MSAT team.

Skills

Leadership

Cross-functional collaboration

Regulatory understanding

Education

B.S./M.S./Ph.D. in Chemical/Biochemical/Biomedical Engineering or related

Job description

AstraZeneca GmbH in Gaithersburg, MD is seeking a Site MSAT Leader to 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.

You will build, mentor, and develop a high-performing Site MSAT team with deep expertise in cell therapy GMP operations and process science and technology, and represent MSAT in technology transfer, process validation, and commercial supply efforts.