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Profile

Shantanu Sule

Principal Scientist

Amgen

Country or State

United States

Bio

• Principal Scientist with ~10 years of experience in biologic parenteral drug product development • Drug Product leadership on multiple early- and late-stage CMC programs, across diverse modalities and combination products, authoring regulatory filings, briefing documents and response to questions • Experience managing multiple staff at junior and senior level, including other drug product leads, building an agile team, and leading department initiative teams • Clinical and Commercial Tech Transfer experience with internal and contract manufacturing sites • Leadership of preclinical research and CMC activities for proof-of-concept clinical studies – novel compounded formulations for improved patient convenience • Training development for platform fill-finish process design approach at Amgen • Recipient of 2013 W.H. Peterson Award at ACS for a novel high-throughput assay (AC-SINS)

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Current Position

Principal Scientist at Amgen

Degrees

Doctor of Philosophy (PhD), Chemical Engineering

Skills