Narayan C Chaudhuri Ph D Organic Chemistry
About
Narayan C Chaudhuri Ph D Organic Chemistry is from Greater Boston. Narayan is currently Executive Director of Process Chemistry, cGMP Manufacturing, and CMC Product Development at Atea Pharmaceuticals, Inc, located in Boston, Massachusetts, United States.
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Narayan C Chaudhuri Ph D Organic Chemistry's current jobs
Technical lead of CMC chemical process and product development of Atea’s novel, transformative antiviral therapies for HCV, dengue, RSV, SARS, MERS, and COVID-19. Oversee manufacturing development, technology transfers, analytical development, and cGMP manufacture of novel drug substance (DS) and drug product (DP) processes at external CDMOs and CMOs supporting Atea’s clinical development programs. Review, verify, recommend, and approve technical data packages of drug stability time points, process transfer protocols, CMC change controls, batch production records, specifications, and batch release documents facilitating CMC product development. Assess risks, deviations, investigations, and root cause analysis, implement CAPAs, and verify effectiveness checks ensuring quality documentation of CTM manufacture. Author, review, and verify CTD Quality Modules of IND, IMPD, CTA, NDA, and MAA submission dossiers facilitating regulatory filings to FDA, EMA, MHRA, PMDA, ANVISA, and rest of the world. Collaborated with Hoffmann-La Roche and Genentech on tech transfer and CMC authoring of a joint COVID-19 development program enabling a number of Ph 3 CTA and IMPD submissions during 2020-2021.