Olivier Dirat

Olivier Dirat serves as the PhRMA Deputy Topic Lead for the ICH Q13 Novel Guideline on "Continuous Manufacturing of Drug Substances & Drug Products" since March 2023, and has been with Pfizer since February 2006, currently holding the position of Senior Director in the GCMC Advisory Office. With extensive experience in regulatory submissions and expertise in starting materials, Olivier has successfully led multi-disciplinary teams in chemical development, focusing on cost-effective and quality-centered API manufacturing processes. Prior roles at Pfizer include Research Fellow and Associate Research Fellow, managing late-stage development candidates through commercialization, and holding leadership responsibilities in various technical and regulatory aspects. Earlier experience includes positions at Merck Sharp and Dohme as a Senior Research Chemist in Medicinal Chemistry and a postdoctoral fellowship at Stanford University. Olivier holds a PhD in Organic Chemistry from Paris-Sud University and a postdoctoral degree from Stanford University.