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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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