- Busy small pharma in Tri-Valley of San Francisco Bay Area with several late stage NDA-track programs.
- Seeking organic chemist or chemical engineer to act as lead process chemist directing CMO activities for late-stage API chemical development programs to advance them from Phase III to NDA stage.
- Apply several years of seasoning leading late-stage drug substance development and production projects.
Academic degree in Organic Chemistry (PhD preferred) or degree in Chemical Engineering.
8 to 15 years’ seasoning in late-stage API process chemistry leadership in the following technical areas:
- Advancing API chemical development projects from Phase III to NDA stage as lead process chemist singularly managing CMO activities.
- GMP DoE leadership for late-stage API chemical development and manufacturing projects.
- Independent review and approval of API / drug substance Phase III manufacturing batches and NDA manufacturing batches within defined timelines.
- Planning activities necessary for scalability of the API process; leading tech transfer to CMOs.
- Designing and leading process validation studies, studies using proven acceptable range (PAR) and design space approaches.
Strong understanding of CMC requirements of FDA filings, including NDAs.
May require up to 30% travel.
HOW TO APPLY:
Use link or, better yet, email resume directly to firstname.lastname@example.org -On subject line, use job code Dir-API-NDA