Associate Director, CMC, Drug Substance
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
-
Healthcare
Job Description & How to Apply Below
Associate Director, CMC, Drug Substance, to oversee development and manufacturing of small molecule APIs for clinical trials in a biopharma setting.
Responsibilities- manage API process development and cGMP manufacturing campaigns via CDMOs
- evaluate and select vendors
- facilitate technology transfer
- collaborate with supply chain to align manufacturing plans with clinical demand
- author and review regulatory CMC documents for IND/NDA/MAA submissions
- participate in audits
- manage API budgets
- PhD in Chemistry or related field with 10+ years of pharma/biotech experience
- proven track record managing API development at CDMOs
- expertise in cGMP regulations
- authoring regulatory sections
- vendor management
- experience with global filings
- strong communication skills
- ability to travel up to 15%
- experience in virtual manufacturing settings
- focus on small molecule APIs
- late-stage development
- regulatory filings
- international collaboration
- API process tech transfer
based in Boston, MA, with potential remote options; international travel may be required.
Position Requirements
10+ Years
work experience
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