Sr. Director/Exec. Director- CMC, Drug Product
Job in
San Francisco, San Francisco County, California, 94199, 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
Lead technical activities related to drug product CMC at CDMOs, focusing on clinical trial material production, process troubleshooting, validation, and regulatory documentation.
Responsibilities:oversee manufacturing processes, provide scientific guidance to external partners, lead process development and validation, and ensure compliance with GMP, FDA, EMA, ICH standards; manage batch records, technical reports, and regulatory submissions; collaborate with Quality and Supply Chain teams to meet deadlines and mitigate risks.
Requirements:- PhD in chemistry, pharmaceutical sciences, or related field
- 12+ years industry experience with at least 8 years focused on antibodies
- proved expertise managing biologics CMC, analytical methods (HPLC, LC-MS, etc.), and regulatory filings (IND/NDA/MAA).
experience leading CDMO from cell line development through IND/FIH, strong leadership, and effective communication skills.
High Value:- biologics
- antibodies
- CMC development
- process validation
- regulatory filings
- GMP compliance
- cross-functional collaboration
not specified.
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