María José López Barragán, PhD FDA

María José López-Barragán currently acts as a Quality Assessment Lead in the Division of Microbiology Assessment, within the Office of Pharmaceutical Quality at the Center for Drug Evaluation and Research. Her current responsibilities focus on the review of Biologic License Applications from microbiology product quality and sterility assurance perspectives, as well participating and leading pre-license inspections of manufacturing sites. Dr. López-Barragán joined the FDA in 2015 after holding several private sector positions as Senior and Principle Scientist, both in Europe and the U.S., spanning from the discovery of new drugs against infectious diseases to the interpretation and discovery of novel genetic variants associated with complex clinical syndromes. Dr. López-Barragán received her PhD in Biochemistry and Molecular Biology from Complutense University of Madrid (Spain) and completed a five-year postdoctoral research program at the U.S. National Institute of Allergy and Infectious Diseases, authoring over twenty peer-reviewed scientific publications.