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Associate Director, CMC Lead

AstraZeneca · Boston, MA

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Role summary

Associate Director leading chemistry, manufacturing, and controls strategy for early-stage alpha-emitting radioconjugate programs. Will develop IND-enabling plans, coordinate API and drug product development, and manage clinical supply strategies across a portfolio of oncology candidates.

What they're looking for

  • 7+ years pharmaceutical or biopharmaceutical product development and manufacturing experience
  • Bachelor's degree; advanced degree in chemistry, pharmaceutics, or chemical engineering preferred
  • Demonstrated CMC development experience including IND-enabling activities and analytical method development
  • Strong project leadership managing multiple concurrent early-stage programs
  • Cross-functional collaboration and stakeholder influence skills across matrix organization
  • Phase-appropriate pharmaceutical strategy development across API, drug product, and analytical areas
  • Problem-solving ability in data-limited, ambiguous early-stage environments

What you'll be doing

  • Define and deliver pharmaceutical development strategy for pre-IND portfolio to drive first-in-human readiness
  • Lead CMC regulatory strategy and author IND/IMPD documentation and data packages
  • Coordinate API, drug product, and analytical development to establish scalable, robust processes
  • Build clinical supply strategies for Phase 0/I aligned with isotope availability and study timelines
  • Manage portfolio priorities and risk assessments across multiple early-stage programs
Compensation$136,514–$204,771 USD base annual

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