Meet’s well-established biotech partner has partnered with us on an exciting new search for a Director of Drug Substance Development. You will be responsible for oversight with CRO/CMO activities for small molecule drug substance development across early and late stage. This is an excellent opportunity to join a veteran CMC group to develop and commercialize oncology and immunology therapies!
Job Overview:
- Lead small molecule API CMO activities in phase-appropriate development
- Troubleshoot and work cross functionally with inhouse and external teams
- Author and contribute to writing CMC sections of regulatory documents (NDA/IND/IMPD/MAA)
- Assess and institute novel strategies while considering scalability, robustness, and feasibility in a cGMP environment
Skills Required:
- PhD in Organic Chemistry, or a related field with 10+ years of experience in the pharmaceutical/biotech industry in small molecule development
- Process validation experience required, authoring/supporting NDA filings is a plus
- Experience mentoring/managing chemists in lab is a plus
If interested in taking your career to the next level, please contact Cayla Koch on +1 646-822-3491 or email cayla@peoplewithchemistry.com if you would like to know more about this opportunity. This will be 100% confidential.
