Mike Fiske is Vice President of Manufacturing Sciences at Scorpius, which operates a multi-use, cGMP-compliant, contract manufacturing facility designed for the development and manufacture of advanced therapies. He has more than 30 years in the biotechnology industry as a protein chemist, analytical biochemist, process development scientist and cGMP operations manager. As Vice President, Mike provides leadership for all aspects of ongoing facility operations, including new facility design, construction and validation, technology transfer, process and analytical methods development, cGMP manufacturing as well as characterization and QC release testing of preclinical and clinical grade advanced therapy biologic products. He also helps clients with preparation of regulatory documents and interactions with regulatory agencies. Mike has an extensive background in cGMP compliance, including manufacturing facility design, construction, and validation. He also has considerable experience in biologics process development, analytical test method development, and validation, as well as cGMP manufacturing and QC release testing of clinical-grade biologics including vaccines, protein therapeutics and cell therapy products.
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