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Director, Small Molecule Drug Substance Development
148142
Posted:
08th
September 2024
- 200000 USD - 230000 USD
- Brisbane, United States
- Permanent
Meet’s well-established biotech partner has engaged 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:
- A 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
Contact Details:
- Please contact Amit Uma on +1 628-336-2772 or email amit@peoplewithchemistry.com if you would like to know more about this opportunity. This will be 100% confidential.
Sarah McGraw
Division Manager