Shawn Larson PhD U.S. FDA

Shawn Larson is a member of the FDA’s Advanced Medical Product Manufacturing team, dedicated to enhancing the FDA's capability in conducting advanced manufacturing and medical countermeasure inspections by augmenting field inspection programs. This team is a cross-cutting initiative supporting the FDA’s Drug, Biologic, and Medical Device inspectorates. As Development Coordinator, Shawn interfaces with both internal and external stakeholders to disseminate knowledge on advanced industry topics, including technological advances in manufacturing equipment, continuous manufacturing, artificial intelligence, and distributed manufacturing. Previously, Shawn served as a Senior Compliance Officer in the FDA’s Drug Inspectorate, where he worked on inspection compliance and compounding pharmacy operational policy. His responsibilities included leadership positions within working groups for operational policy, as well as case management of consent decrees and warning letters, among other actions to achieve compliance with the Food, Drug, and Cosmetic Act. Trained as an FDA Investigator, Shawn has experience in human and animal drugs, biotech, active pharmaceutical ingredients, and pharmacy compounding. He provides training and professional development to investigator staff as both a technical expert and a training coordinator. Shawn earned his Doctor of Philosophy in Chemistry from the University of South Florida, where his research focused on organocatalysis methodology.