CMC Product Leader, Senior Director - T1D
Job in
Boston, Suffolk County, Massachusetts, 02298, USA
Listed on 2026-10-06
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-10-06
Job specializations:
-
Pharmaceutical
Regulatory Compliance Specialist, Pharmaceutical Manufacturing -
Management
Regulatory Compliance Specialist
Job Description & How to Apply Below
Senior Director, CMC Product Leader (T1D) for cell therapy; responsible for developing and executing integrated CMC strategies across development, scale-up, validation, regulatory submission, and commercialization.
Core responsibilities- leading cross-functional teams covering process and analytical development, technology transfer, manufacturing readiness, regulatory strategy, and lifecycle management
- partnering with stakeholders across Biopharm Sci CGT, Manufacturing, Quality, Regulatory, Clinical, and Commercial functions
- guiding technology transfer, manufacturing scale-up, and risk mitigation
- preparing CMC content for regulatory filings
- managing budgets and resources
- Advanced degree in Chemical Engineering, Biotechnology, Biochemistry, or related field
- 10+ years in CMC development and manufacturing within biotech/pharma, with significant cell therapy or regenerative medicine experience
- proven leadership at Director or Senior Director level
- experience with process development, regulatory submissions, and manufacturing scale-up
- PhD or MBA
- experience in process validation, regulatory interactions, and commercialization of complex biologics
- cell therapy
- regenerative medicine
- CMC development
- process transfer
- regulatory strategy
- scale-up
- validation
- IND/CTA/submission experience
- Hybrid or on-site
- flexible work arrangements
Position Requirements
10+ Years
work experience
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