Cmc Program Lead

Telix Pharmaceuticals

Remote
Remote
10+ years radiopharmaceutical cmc experience
5+ years cmc program management experience
Experience with biologics and antibody conjugates
The role involves leading the CMC Sub-Team and serving as the single point of contact for all CMC topics on the program matrix

Job Summary

  • The role involves leading the CMC Sub-Team and serving as the single point of contact for all CMC topics on the program matrix.
  • The position requires developing, executing, and maintaining an integrated CMC strategy grounded in Quality by Design principles from preclinical through end of phase 1.
  • Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company dedicated to improving the quality of life for people living with cancer and rare diseases.

Matching Summary

The role involves leading the CMC Sub-Team and serving as the single point of contact for all CMC topics on the program matrix.

Skills & Requirements

Must-have

  • 10+ years radiopharmaceutical CMC experience
  • 5+ years CMC program management experience
  • Experience with biologics and antibody conjugates
  • Knowledge of Quality by Design (QbD) principles
  • Expertise in FDA and global regulatory requirements
  • Experience managing cross-functional matrix teams

Nice-to-have

  • Strong communication and collaboration skills
  • Adaptability in dynamic global environments
  • Inclusive mindset and ethical behavior
  • Ability to drive innovation and creativity
  • Resilience in facing challenges

Key Requirements

  • BA or BS degree in Science, Mathematics, Engineering, or related field
  • 10+ years relevant radiopharmaceutical/pharmaceutical/biopharma CMC experience
  • 5+ years CMC program/project management experience
  • Experience managing pharmaceutical alliance/partnership programs
  • Robust knowledge of IND, NDA/BLA regulatory requirements

Work Rights

Not specified

Tailored Resume

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