J Paul Kirwan

Placeholder Person Graphic
Amgen Inc
Senior Manager, Regulatory Affairs CMC
J. Paul Kirwan is a Sr. Manager, Regulatory Affairs CMC, with Amgen since 2018. Paul currently manages the CMC content and regulatory strategy of module 3 authoring templates and is contributing to the development of tools for structured content authoring. He is a member of the advocacy and external engagement team, supports regulatory policy, and previously served as Global CMC Regulatory Lead for several clinical stage programs with multiple indications and filings in several countries.

Prior to joining Amgen, Paul was a product quality CMC review chemist at FDA/CDER in the Office of Biotechnology Products. 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.

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.

Related Articles

Barriers to Innovation in Pharmaceutical Manufacturing Insights From Five Case Studies
Features
Barriers to Innovation in Pharmaceutical Manufacturing Insights From Five Case Studies

In April 2023, ISPE launched a survey to understand the sources of barriers to technological innovation within the pharmaceutical industry. This survey is part of an expansive and significant initiative by ISPE, Enabling Global Pharma Innovation: Delivering for Patients, which aims to promote consistent and harmonized interpretation and implementation of guidelines issued by the International...