Contact: Marc Miller
Phone: 215-830-9211 x109
Seeking a motivated process chemist to lead drug substance process research and manufacture of small molecule candidates from Phase I through NDA. The successful candidate needs to demonstrate a proven track record of managing CROs and CMOs successfully to conduct process research and manufacture under GLP and cGMP of small molecule drug candidate to support Phase I to commercial drug substance needs. Experience with filing drug substance sections in IND and NDA submissions is also desired.
- Guide CRO to design and perform process development experiments at different stages of development (pre-clinical through Phase 3).
- Supervise CMO to manufacture drug substances under GLP and cGMP to supply drug substances for toxicology studies, clinical trials and commercial use
- Familiar with QBD approach to develop robust process for drug substance manufacture
- Author process development reports and drug substances sections in IND and NDA filings
- Work collaboratively with medicinal chemists to ensure a smooth transition in making drug substance supply from a medicinal chemistry route to a scalable route
- Will perform other CMC related duties as required.
- PhD in organic chemistry with 5+ years of process chemistry experience
- Excellent scientific knowledge in organic chemistry and process chemistry
- Effective verbal and written communication skills
- Experience in managing CROs and CMOs.
- Experience and ability to draft drug substance sections of INDs and NDAs.
- Experience in drafting, reviewing and submitting required documentation pertaining to the development and preparation of drug substances under cGMP environment.
- A proven track record of scaling-up and delivering kg quantities of experimental drug substance in the appropriate physical form.
- Ability and track record of successfully working in cross-functional teams to progress projects
- Ability to navigate and be successful in a fast-paced, highly-matrixed work environment
- Willingness to “roll up his sleeves” and do what it takes to achieve objectives.
- Potential to grow as a scientific and organizational leader along with the growth of the company and its portfolio.
- A desire to be part of a highly innovative company aimed at helping patients with serious diseases
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