Associate Director, Cmc

Fusion Pharmaceuticals

Hamilton, Canada
Base: 131,201.60 to 172,202.10; bonus/equity: annu...
Not specified
Radiopharmaceutical manufacturing strategy
Cdmo selection and management
Process development and optimization
Fusion Pharmaceuticals is seeking an Associate Director for CMC to oversee the manufacturing strategy for radiopharmaceutical conjugates, driving compliance and process optimization from development through commercialization. The ideal candidate will have extensive experience in biotech or pharmaceutical manufacturing processes, with a focus on regulatory compliance and cross-functional collaboration

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.
  • We foster a collaborative, innovative culture with opportunities to work across teams, functions, and geographies—where your ideas move fast and your impact is visible.

Matching Summary

Match Score: 85

Fusion Pharmaceuticals is seeking an Associate Director for CMC to oversee the manufacturing strategy for radiopharmaceutical conjugates, driving compliance and process optimization from development through commercialization. The ideal candidate will have extensive experience in biotech or pharmaceutical manufacturing processes, with a focus on regulatory compliance and cross-functional collaboration.

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

  • Radiopharmaceutical manufacturing strategy
  • 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
  • Thriving in a fast-paced environment
  • Sustainability and equity commitment

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 API manufacturing processes
  • Proven ability to manage US and international CRO/CDMOs
  • Solid understanding of regulatory compliance requirements

Work Rights

Not specified

Tailored Resume

Cover Letter