Senior Biologist
FDA CDER’s Office of Pharmaceutical Quality Research, Division 6
Scott Lute is a Senior Biologist in FDA CDER’s Office of Pharmaceutical Quality Research, Division 6. He has been with CDER since 2002 performing applied manufacturing and safety research, CMC regulatory assessment, and inspections for biologics. His research focuses on regulatory concerns related to protein therapeutic manufacturing, particularly those associated with product quality, viral safety, and novel technologies implemented for advanced manufacturing processes. He has collaborated with academics, industry, and vendors to publish >60 scientific manuscripts with the aim to increase the overall knowledge of downstream processes and to make safer, high quality drug products.