Associate Director, Cmc

Fusion Pharmaceuticals

Hamilton, Canada
Base: $131,201.60 - $172,202.10; bonus/equity: ann...
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Radiopharmaceutical conjugate manufacturing
Cdmo selection and management
Process development and optimization
** Fusion Pharmaceuticals is seeking an Associate Director for its manufacturing strategy in radiopharmaceutical conjugates, focusing on process development, optimization, and cGMP compliance. The ideal candidate will have a strong background in biotech manufacturing, particularly in API processes, and will be responsible for managing CDMO relationships and ensuring timely delivery of clinical and commercial supplies. **

Job Summary

  • This role leads end-to-end execution of AstraZeneca’s manufacturing strategy for radiopharmaceutical conjugates, owning CDMO selection and management for process development, optimization, tech transfer, and cGMP manufacturing of precursor materials from preclinical through commercialization.
  • The leader proactively identifies process gaps and CMC risks, partners with global teams to implement mitigation plans and continuous improvements, and guides development, qualification/validation, and transfer of analytical methods and specifications for targeting moieties.
  • Acting as the technical subject matter expert with Health Authorities, they contribute to CMC authoring and responses, enable inspection readiness, and drive on-time, in-full delivery of clinical and commercial supply while meeting quality, cost, and timeline objectives across a global, matrixed environment.

Matching Summary

Match Score: 75

** Fusion Pharmaceuticals is seeking an Associate Director for its manufacturing strategy in radiopharmaceutical conjugates, focusing on process development, optimization, and cGMP compliance. The ideal candidate will have a strong background in biotech manufacturing, particularly in API processes, and will be responsible for managing CDMO relationships and ensuring timely delivery of clinical and commercial supplies. **

Salary

Base: $131,201.60 - $172,202.10; Bonus/Equity: Annual Variable Pay Bonus/Short Term Incentive opportunity and potential equity; Benefits: Flex Benefits & Retirement Savings Program, 4 weeks' paid vacation, annual Personal Days

Skills & Requirements

Must-have

  • Radiopharmaceutical conjugate manufacturing
  • CDMO selection and management
  • Process development and optimization
  • cGMP manufacturing compliance
  • Analytical method development and validation
  • Health Authority interactions

Nice-to-have

  • Collaborative and innovative culture
  • Fast-paced start-up environment
  • Commitment to sustainability and equity
  • Solid-phase peptide synthesis
  • Bioconjugation experience

Key Requirements

  • Master's or Ph.D. in Chemistry, Chemical Engineering, or related field
  • Minimum 5 years in process development and manufacturing
  • Experience developing phase-appropriate API manufacturing processes
  • Proven ability to manage U.S. and international CRO/CDMOs
  • Solid understanding of regulatory compliance (FDA, GMP, EHS)
  • Hands-on experience with process scale-up and technology transfer

Work Rights

Not specified

Tailored Resume

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