Sr. Director/ Exec. Director- CMC, Drug Product

Role: 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; proven expertise managing biologics CMC, analytical methods (HPLC, LC-MS, etc.), and regulatory filings (IND/NDA/MAA). Preferred: experience leading CDMO from cell line development through IND/FIH, strong leadership, and effective communication skills. HighValue: biologics, antibodies, CMC development, process validation, regulatory filings, GMP compliance, cross-functional collaboration. WorkSetup: not specified.