Thomas O'Connor, PhD FDA

Dr. O’Connor is a senior chemical engineer in Division of Product Quality Research in the OPQ’s Office of Testing and Research and is a member of CDER’s Emerging Technology Team. His responsibilities included coordinating and directing regulatory science projects to support the implementation of emerging technologies in pharmaceutical manufacturing. His team’s independent research has centered on advancing the utilization models to aid the risk assessment of advanced manufacturing processes. He originally joined the FDA as chemistry reviewer in the Office Generic Drugs and has served as a primary and secondary reviewer for ANDAs and controlled correspondence. Tom is a co-author of several papers and book chapters on continuous manufacturing and emerging technology.

Prior to joining the FDA, Tom worked at ExxonMobil Research and Engineering where he held job functions in both process analytical technology and process control. Before leaving he was the technology owner for a set of operator guidance tools including fault detection. He is an experienced practitioner of advanced process control techniques including statistical process control and holds patents related to the development of statistical monitoring systems for industrial plants. Dr. O’Connor earned a B.S. in chemical engineering from the Cooper Union and a Ph.D. in chemical engineering from Princeton University.