**Seeking candidates in the Bay Area**
Meet’s fast moving biotech partner has engaged us on an exciting new search for a Senior Director of Small Molecule Drug Substance. You will be responsible for oversight with CRO/CMO activities for small molecule drug substance development across late stage. This is an excellent opportunity to join a growing CMC group that plans to commercialize their late stage rare disease drugs, which have Breakthrough and Fast Track Designations in the U.S., as well as Orphan Drug Designation in the US and EU. This is the time to join!
Job Overview:
- Lead in the development, optimization, and scale up of drug substance across late stage - ensuring scalability and robustness across precommercial activities
- Troubleshoot and work cross functionally with inhouse and external teams
- Lead in the design and implementation of supply chain processes
- Author and contribute to writing CMC sections of regulatory documents (NDA/IND/IMPD/MAA)
- Mentor and lead other members across the CMC organization
Skills Required:
- A PhD in Organic Chemistry, Chemical Engineering, Chemistry or a related field with 10+ years of experience in the pharmaceutical/biotech industry - a MS or BS can also be considered with more relevant years of industry experience
- Expertise in small molecule drug substance - ideally with having overseen both DS and DP development functions - solid oral dosage, modified release, and pediatric formulations
- Highly experienced in CRO/CMO selection and management across a global network
- Experienced in process validation and authoring/supporting NDA filings - commercialization experience is a preferred
- You are a CMC leader from small biotech
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.
