Sean Goudy, PhD Biogen

Sean Goudy has a Ph.D. in Mechanical Engineering, and he is a licensed Professional Engineer. His masters and doctoral work were in the areas of computational and experimental fluid dynamics. Dr. Goudy has over 17 years of pharmaceutical experience, and he has worked for several pharmaceuticals companies. His current role is Associate Director, Technical Development at Biogen in Research Triangle Park, NC. Dr. Goudy was instrumental in the startup, tech transfer and licensure of multiple aseptic filling lines. He also has extensive knowledge of isolator technology, validation, aseptic processing, and the development of Vapor Phase Hydrogen Peroxide (VPHP) cycles. He has presented to a variety of Health Authorities: US Food and Drug Administration (FDA), European Medicines Agency (EMA), Health Canada/Santé Canada, Japanese Pharmaceutical and Medical Devices Agency (PMDA), and Brazilian Agência Nacional de Vigilância Sanitária (ANVISA). Dr. Goudy has presented at national and international conferences.