Thomas O’Connor, PhD
Division Director, Division of Product Quality Research, Office of Testing and Research, OPQ, CDER
Dr. O’Connor is the director of the Division of Product Quality Research in the Office of Testing and Research in the Office of Pharmaceutical Quality and is a member of CDER’s Emerging Technology Team (ETT). His responsibilities include managing research and testing projects that answer and anticipate pharmaceutical quality-related regulatory challenges through scientific approaches. The impact of OTR research and testing is utilized to support regulatory assessment and policy development in areas such advanced manufacturing, drug quality standards, characterization of complex drug substances and drug products, and post market product quality and public health issues. Tom is a co-author of several papers on emerging pharmaceutical technology (such as continuous manufacturing, 3D printing, and the utilization of modeling and simulation for quality assurance). Through the ETT he has contributed to the review of several regulatory applications utilizing novel technologies. He is the co-chair of the OPQ Manufacturing Science and Innovation Center of Excellence and is a member of the advanced manufacturing working groups within the FDA.
Tom originally joined the FDA as chemistry reviewer in the Office Generic Drugs and 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. Dr. O’Connor earned a B.S. in chemical engineering from the Cooper Union and a Ph.D. in chemical engineering from Princeton University.