Derek Smith

Derek Smith received his B.S. in Physics from Washington College (2003) and his Ph.D. in Chemical and Biochemical Engineering from University of Maryland, Baltimore County (2008). He completed a NRC postdoctoral fellowship at NIST (2008-2010) prior to joining the CDER’s Office of Compliance. There, he spent 2 years in the Division of Good Manufacturing Practice Assessment as a compliance officer for pre-approval facility evaluations. Later, he joined Office of Generic Drugs as a CMC reviewer of ophthalmic, topical, and injectable drug products. In these positions, he was involved in several important regulatory initiatives including Quality by Design, Process Analytical Technologies, and the Risk-Based Review Initiatives. In the Office of Pharmaceutical Quality, Derek has served as a Quality Assessment Lead (Acting) and is currently a Branch Chief in the Office of Process and Facilities where he oversees the assessment of the manufacturing process and facilities for small molecule drug applications and INDs with a focus on the integration of application assessment and inspection findings, as well as the data reliability assessments.
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