Senior Director, Manufacturing Science and Technology, Cell Therapy Technical Operations
AstraZeneca
AstraZeneca seeks a Senior Director of Manufacturing Science and Technology to lead cell therapy manufacturing operations across global sites. The role oversees process validation, commercialization, and lifecycle management while building and managing a specialized technical team.
Responsibilities
- Define and execute global MSAT strategy aligned with cell therapy technical operations and supply objectives
- Build, mentor, and develop high-performing global technical team with deep cell therapy expertise
- Oversee cell therapy manufacturing lifecycle from tech transfer and process validation through commercialization and post-approval improvements
- Author validation master plans, protocols, and regulatory submissions; lead health authority inspections and compliance activities
- Drive process improvements, risk mitigation, and standardization across manufacturing sites to ensure robustness and supply continuity
Requirements
- B.S., M.S., or Ph.D. in chemical, biochemical, biomedical engineering, bioengineering, biochemistry, biotechnology, or cell biology
- 12+ years progressive experience in cell therapy, biologics, vaccines, or CMC leadership
- Deep technical expertise in cell therapy manufacturing processes, GMP operations, and process validation
- Proven track record leading high-performing teams in technical and cross-functional environments
- Demonstrated success authoring CMC sections for regulatory filings (IND, BLA, MAA) and managing health authority inspections
- Strategic thinker with strong execution discipline and executive-level communication across scientific and regulatory audiences
- Experience with PPQ, CPV, and post-approval process optimization strategies
Vacancy posted more than 2 months ago
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