Process chemist with 27+ year experience at Janssen Pharmaceutical Companies of Johnson & Johnson and Merck Research Laboratories and with a focus on designing, developing and implementing innovative, robust, cost-effective and green manufacturing routes to small molecule APIs. Proven track record of building high performance teams, developing key talent, fostering scientific excellence and delivering results. Industry-recognized expert in the design and development of manufacturing routes to significant drugs and late stage clinical candidates including Esketamine, Canagliflozin, Odalasvir, Cozaar, Maxalt, Sustiva, Januvia, Taranabant, Odanacatib, Omarigliptin, Elbasvir, Vaniprevir, and Doravirine. Exceptional creativity, expertise in inventing new synthetic methodology, and problem solving ability. Excellent knowledge base in all aspects of API production from bench to factory with proven track record of collaborating with cross-functional drug development teams through registration and launch. Chemistry subject expert on Due Diligence of three external drug candidates. Author of >90 publications/patents and invited lecturer for 70 presentations in main stream organic chemistry conferences and universities.
Expertise: multi-step organic synthesis, GMP production of bulk drub substances, new synthetic methodology, asymmetric synthesis, organometallics in organic synthesis and heterocyclic chemistry. Chemistry Subject Matter Expert (SME) for Synthesis Evaluation Review (SER), Potential Genotoxic Impurities (PGI) assessment. GMP compliance by selection of API starting materials, CMC support