J Paul Kirwan

J. Paul Kirwan is a Sr. Manager, Regulatory Affairs CMC, with Amgen since 2018. Paul has been a member of the IQ working group on microbial in-use stability since March 2021. Paul is a CMC science and strategy lead, manages the CMC content and regulatory strategy of module 3 authoring templates, and is a member of the advocacy and external engagement team. He also served as Global CMC Regulatory Lead for several clinical stage programs with multiple indications and submissions in numerous countries. Prior to joining Amgen, Paul was a product quality CMC review chemist at FDA/CDER in the Office of Biotechnology Products from 2014-2018. His responsibilities included product quality review and assessment of biologic and biosimilar submissions across all stages of development, engaging in FDA meetings with sponsors, and contributing to pre-license inspections. He is also a former FDA Commissioner’s Fellow (2013-2014). Additional interests include protein stability and aggregation, formulation development, clinical relevance of quality attributes, advanced manufacturing principles, and applications of artificial intelligence in CMC and clinical development. 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.