Dr. John Amedio serves as Acting Head of Manufacturing. Dr. Amedio’s experience spans more than 30 years in the pharmaceutical industry. He most recently served as SVP of Technical Operations at ArQule, a subsidiary of Merck & Co., where he was responsible for global manufacturing operations and drug supply.
Dr. Amedio has delivered profitable and patented drug substances and drug products from pre-clinical through commercial phases and has authored/co-authored CMC sections for numerous regulatory filings. As Principal at Amedio CMC Consulting, he specialized in providing strategy for the technical and regulatory CMC development processes for biotechnology and pharmaceutical companies working to bring drugs through to market. Previously, Dr. Amedio served in several manufacturing guidance leadership roles, including positions at Seaside Therapeutics, ZIOPHARM Oncology, EPIX Pharmaceuticals, and Sandoz Research Institute.
He holds a Ph.D. in Organic Chemistry from the University of Delaware and earned his B.S. in Chemistry from Manhattan College. Dr. Amedio completed his post-doctoral research in Natural Product Synthesis and Organic Chemistry at Oregon State University.
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