Global MSAT Director - Cell Therapy Manufacturing

AstraZeneca plc; Gaithersburg (MD); Hybrid; USD 217,000 - 325,000; Full time

Job summary

AstraZeneca plc is seeking a Senior Director of Manufacturing Science and Technology (MSAT) to lead end-to-end cell therapy manufacturing across a global network of sites, overseeing tech transfer, process validation, commercialization, and lifecycle management.

You will build and mentor a high-performing MSAT team, drive regulatory readiness, continuous process verification, and collaborate across CMC, regulatory, quality, and supply chain to ensure robust, compliant operations.

Qualifications

• 12+ years of progressive experience in cell therapy/biologics/vaccines within tech development or manufacturing leadership.
• Proven ability to lead and mentor high-performing technical teams.
• Strong track record authoring CMC sections for major regulatory filings (IND/BLA/MAA).
• Experience with GMP manufacturing operations, process validation, PPQ, CPV, and regulatory readiness.

Responsibilities

• Define and execute the Global MSAT function strategy across clinical and commercial stages.
• Build, mentor, and develop a global MSAT team with deep cell therapy expertise.
• Represent MSAT in technology transfer and process characterization for successful commercialization.
• Develop PPQ readiness and CPV frameworks for site MSAT teams and oversee site execution.
• Lead regulatory submissions support and health authority inspection readiness.

Skills

Team leadership

Regulatory submissions (CMC)

Strategic planning

Cross-functional collaboration

Education

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

Job description

AstraZeneca plc is seeking a Senior Director of Manufacturing Science and Technology (MSAT) to lead end-to-end cell therapy manufacturing across a global network of sites, overseeing tech transfer, process validation, commercialization, and lifecycle management.

You will build and mentor a high-performing MSAT team, drive regulatory readiness, continuous process verification, and collaborate across CMC, regulatory, quality, and supply chain to ensure robust, compliant operations.