Martin Osterhout
Senior Director CMC at Metavant Sciences, Inc.
- Role
- Senior Director Pharmaceutical Development at Roivant
- Location
- Raleigh, NC, US
- LinkedIn followers
- 500 followers
About Martin Osterhout
Diverse experience in the synthesis, discovery and development of NCEs in Pharma and the management of CMC programs from early lead identification through marketing applications (Tykerb/Tyverb $338 million in 2013 sales and Potiga/Trobalt $19 million in 2013 sales). Experience in providing tactical and operational management of drug development activities (15+ projects) by leading teams composed of synthetic and analytical chemists, particle scientists, and chemical engineers working in multiple areas of development of drug candidates. Areas include: scaleup / manufacture adherence to cGMP and regulatory requirements, quality & EHS issues, technology transfer to pilot plants and commercial manufacturing facilities, utilization of Risk Management tools to develop a control strategy for drug substance manufacture and process qualification using guidance provide in ICH Q8-11. As a result of these efforts, I have co-authored CMC sections and been part of regulatory submission teams filing INDs and IMPDs (Phase 1-3), IND Amendments, IBs, and NDA/sNDA.
Experience
Senior Director Pharmaceutical Development
Jul 2015 — Present
Education
Duke University
Bachelor of Science (BS), Chemistry
1981 — 1985
North Carolina State University
Graduate Certificate in Biomanufacturing
2013 — 2014
Indiana University Bloomington
Doctor of Philosophy (Ph.D.), Synthetic organic chemistry
1985 — 1991
Emory University
Post-Doctoral Research Associate – Dept. of Chemistry (1994)
1992 — 1994
Skills
- Hplc
- Ind
- Gmp
- Medicinal Chemistry
- Pharmaceutical Industry
- Lc-Ms
- Scifinder
- Organic Chemistry
- Technology Transfer
- CRO
- Drug Development
- Drug Discovery
- Organic Synthesis
- Analytical Chemistry
- Lead Change
- Chemistry
- Chromatography
- Biotechnology
- Drug Design
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