1d ago
CMC Program Lead
Canada
โจ $175k-$225k / yearest.
full-timelead Remotebiotech
๐ผ 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.
๐ฏ 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
๐ 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
โจ Nice to Have
- Experience with radiochemistry
- Knowledge of FDA, IND, NDA/BLA regulatory frameworks
- CDMO/CMO relationship management
๐ Benefits & Perks
- ๐ฐ Competitive base salary with annual bonus and equity
- ๐๏ธ Generous vacation and paid wellness days
- ๐ Hybrid and remote work flexibility
- ๐ Learning and development opportunities
- ๐ค Collaborative, mission-driven international environment
๐จ Hiring Process
Estimated timeline: 3-5 weeks ยท AI estimate
- 1Recruiter Screenยท 30 min
- 2Hiring Manager Interviewยท 60 min
- 3Technical Interviewยท 60 min
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