Associate Director, Cmc

Fusion Pharmaceuticals

Hamilton, Canada
Base: 131,201.60 to 172,202.10; bonus/equity: annu...
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Cdmo selection and management
Cgmp manufacturing of precursor materials
Process development and optimization
** Fusion Pharmaceuticals is seeking an Associate Director of CMC to oversee the manufacturing strategy for radiopharmaceutical conjugates, ensuring compliance with regulatory standards and managing CDMOs. The role requires extensive experience in process development and manufacturing within the biotech industry. **

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 to ensure robust release, stability, and in‑process control strategies.
  • You’ll join a collaborative, innovative community with opportunities to work across teams, functions, and geographies—where your ideas move fast and your impact is visible.

Matching Summary

Match Score: 75

** Fusion Pharmaceuticals is seeking an Associate Director of CMC to oversee the manufacturing strategy for radiopharmaceutical conjugates, ensuring compliance with regulatory standards and managing CDMOs. The role requires extensive experience in process development and manufacturing within the biotech industry. **

Salary

Base: 131,201.60 to 172,202.10; Bonus/Equity: Annual Variable Pay Bonus/Short Term Incentive opportunity as well as eligibility to participate in equity-based long-term incentive program; Benefits: Competitive Flex Benefits & Retirement Savings Program, 4 weeks’ paid vacation, and annual Personal Days

Skills & Requirements

Must-have

  • CDMO selection and management
  • cGMP manufacturing of precursor materials
  • process development and optimization
  • analytical method development and validation
  • regulatory agency interactions

Nice-to-have

  • cutting-edge science
  • breakthrough science
  • collaborative, innovative culture
  • sustainability and equity

Key Requirements

  • Master's or Ph.D. in Chemistry, Chemical Engineering, or related field
  • Minimum 5 years in process development and manufacturing
  • Demonstrated success in developing phase-appropriate API manufacturing processes
  • Proven ability to manage U.S. and international CRO/CDMOs
  • Hands-on experience with process scale-up and technology transfer

Work Rights

Not specified

Tailored Resume

Cover Letter