1d ago

CMC Program Lead

Canada

โœจ $175k-$225k / yearest.

full-timelead Remotebiotech

๐Ÿ’ผ About This Role

You'll lead end-to-end CMC strategy execution for antibody-based radiopharmaceutical programs, coordinating internal teams and external partners to deliver compliant CMC outcomes. This role offers high visibility across global program teams and a direct impact on innovative therapies for oncology and rare diseases.

๐ŸŽฏ What You'll Do

  • Develop and execute integrated CMC strategies for radiopharmaceutical programs
  • Apply Quality by Design principles to define product profiles and control strategies
  • Act as single point of accountability for CMC matters and lead cross-functional sub-teams
  • Coordinate activities across Drug Substance, Analytical Development, QA/QC, and Regulatory teams

๐Ÿ“‹ Requirements

  • Bachelor's degree in Science, Engineering, or related discipline
  • 10+ years in pharmaceutical or biotech CMC development
  • 5+ years in CMC program management within matrix environments
  • Expertise in biologics (e.g., monoclonal antibodies) and/or radiopharmaceutical development

โœจ Nice to Have

  • Experience with radiochemistry
  • Knowledge of FDA, IND, NDA/BLA regulatory frameworks
  • CDMO/CMO relationship management

๐ŸŽ Benefits & Perks

  • ๐Ÿ’ฐ Competitive base salary with annual bonus and equity
  • ๐Ÿ–๏ธ Generous vacation and paid wellness days
  • ๐ŸŒ Hybrid and remote work flexibility
  • ๐Ÿ“š Learning and development opportunities
  • ๐Ÿค Collaborative, mission-driven international environment

๐Ÿ“จ Hiring Process

Estimated timeline: 3-5 weeks ยท AI estimate

  1. 1Recruiter Screenยท 30 min
  2. 2Hiring Manager Interviewยท 60 min
  3. 3Technical Interviewยท 60 min
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