J. Paul Kirwan PhD Amgen

J. Paul Kirwan is a Senior Manager, Regulatory Affairs CMC, with Amgen since 2018. Paul currently leads regulatory reliance procedures in conjunction with cloud-based regulatory submissions. He also leads the CMC Science and Strategy team which supports structured content and generative artificial intelligence authoring initiatives for regulatory CMC submissions, and manages the initial CMC and regulatory content included in module 3 for clinical and commercial submissions. In addition, he as actively engaged with several external professional associations, consortia, and trade associations. Prior to joining Amgen, Paul was a product quality CMC review chemist at FDA/CDER in the Office of Biotechnology Products and is also a former FDA Commissioner’s Fellow. Paul holds a PhD in Biochemistry from the University of Colorado Anschutz Medical Campus, where he completed graduate and post-doctoral training in the laboratory of Robert S. Hodges.