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.
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