James L. Dunnie, Jr.

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FDA/ORA/OO/OMPTO/DMPTPO
Senior Drug Program Expert
Jim started with FDA in 1983 as an Investigator in the Dallas District/Houston Station Office. In 1989, he was promoted and transferred to the San Juan District Office as a Drug and Biologics Specialist. In 1991, Jim was promoted and become a Supervisory Investigator and transferred to the Baltimore District Office. In 1994, he accepted a lateral transfer to ORA Headquarters – the Division of Field Investigations, as a Program Expert. In 2009, Jim was promoted to a Senior Drug Program Expert. He became a member of FDA’s foreign drug inspection cadre in 1993 and has been involved with national ORA training of drug investigators since 1996. Jim is also an ORA representative to the FDA Inter-Agency Combination Products cGMP Workgroup. Jim earned a B.S. in Environmental Science from The Pennsylvania State University in 1982. In 1989, he completed a M.B.A. from the University of Houston.