Celia Cruz PhD

Dr. Celia Cruz is an Acting Branch Chief in the Office of Process and Facilities (OPF) within CDER's Office of Pharmaceutical Quality. She has a Ph.D. in Chemical Engineering from Carnegie Mellon University. Before joining the FDA in 2010, Dr. Cruz worked in industry for eleven years, where she led teams responsible for the development and commercialization of solid oral drug products. This included manufacturing process development, materials characterization and technology transfer. As a black belt in Six Sigma, she was an early adopter of Quality by Design and the use of quality risk assessments for guiding drug product development. Within FDA, Dr. Cruz has served as a reviewer for new and generic drugs, a liaison for Quality by Design within team reviews, and as a Lead of the CDER Nanotechnology Working Group. She has presented on the use of risk assessments for product development and review and is currently involved in the FDA efforts on continuous manufacturing.