Maria Gutierrez-Hoffmann PhD U.S. FDA

Maria Gutierrez-Hoffmann is a Pharmaceutical Manufacturing Assessor in the Center for Drug Evaluation and Research at the Food and Drug Administration, where she conducts assessments of drug substance and drug product quality modules of Biologics License Applications and supplemental submissions, from a Microbiology perspective. She also participates in establishment inspections of drug substance and drug product manufacturing facilities. Maria earned a Ph.D. in Microbiology from the University of Louisville and conducted post-doctoral research in Immunology at Johns Hopkins University.