Product Quality Research Institute – Just another WordPress … · Web viewHe has interacted with...
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Dr. Ambarish K Singh Director, Global Regulatory Sciences-CMC Work Address : Bristol-Myers Squibb Company PO Box 5400, Princeton, New Jersey 08543 email: [email protected] Phone: 609-818-6952 Home (mailing address) 1 Gardenia Court Plainsboro, NJ 08536 Bio: Ambarish Singh holds a PhD in Organic Chemistry from the State University of New York at Stony Brook. He served as a post- doctoral fellow at Fox Chase Cancer Center, Philadelphia and Memorial Sloan Kettering Cancer Center, New York. Dr. Singh started his industrial career by joining the Process Research and Development department of Bristol-Myers Squibb Company and contributed heavily to the chemical process development of numerous commercial products, such as Fungizone, Pravachol, Taxol and Baraclude. He has led several successful "start-ups" to transfer laboratory processes to manufacturing sites in Ireland, Italy and Puerto Rico. Ambarish has also led a cross-functional team responsible for developing, manufacturing and filing of the marketing application for Onglyza, a DPP4 inhibitor for the treatment of Type II diabetes. In 2007, Ambarish transitioned into Global Regulatory Sciences- Chemistry, Manufacturing and Control (CMC) department, where he is a director and responsible for providing regulatory-CMC guidance and strategies for projects that are in development.
Transcript of Product Quality Research Institute – Just another WordPress … · Web viewHe has interacted with...
Dr. Ambarish K Singh
Director, Global Regulatory Sciences-CMC
Work Address:
Bristol-Myers Squibb Company
PO Box 5400, Princeton, New Jersey 08543
email: [email protected]
Phone: 609-818-6952
Home (mailing address)
1 Gardenia Court
Plainsboro, NJ 08536
Bio:
Ambarish Singh holds a PhD in Organic Chemistry from the State University of New York at Stony Brook. He served as a post-doctoral fellow at Fox Chase Cancer Center, Philadelphia and Memorial Sloan Kettering Cancer Center, New York.
Dr. Singh started his industrial career by joining the Process Research and Development department of Bristol-Myers Squibb Company and contributed heavily to the chemical process development of numerous commercial products, such as Fungizone, Pravachol, Taxol and Baraclude. He has led several successful "start-ups" to transfer laboratory processes to manufacturing sites in Ireland, Italy and Puerto Rico. Ambarish has also led a cross-functional team responsible for developing, manufacturing and filing of the marketing application for Onglyza, a DPP4 inhibitor for the treatment of Type II diabetes.
In 2007, Ambarish transitioned into Global Regulatory Sciences-Chemistry, Manufacturing and Control (CMC) department, where he is a director and responsible for providing regulatory-CMC guidance and strategies for projects that are in development. He has interacted with FDA, EMA, Health-Canada and TGA on CMC filing strategies related to QbD/PAT/RTRt.
Ambarish has received several BMS awards (President’s award, Triumph award, Ondetti & Cushman award) for his contributions to the advancement of Science and Technology in Process R&D. He has published >25 scientific articles and holds 6 patents. External to BMS, Ambarish has given several talks on topics related to chemical process development and QbD/PAT/RTRt at universities and conferences. He has served on the scientific advisory board of the Cambridge Healthtech Institute (CHI) and American Chemical Society local chapter-Regulatory-CMC.
