Ingrid Markovic

Genentech, a Member of the Roche Group

Ingrid Markovic, Ph.D. serves as Senior Science Advisor and CMC Policy Lead in the CBER/FDA Immediate Office of the Center Director where she is responsible for providing leadership, strategic direction, and oversight for development, implementation, and integration of CMC policies for biological and biotechnological products. In the international arena, Ingrid serves as CBER ICH Quality Lead, and is/was FDA Topic Lead/(co)Lead for QDG, Q12 and M4Q. She had an opportunity to briefly serve as Q3E Rapporteur. Ingrid previously worked in the industry sector leading US & EU CMC Regulatory Policy efforts with focus on Technological Innovation and Cell & Gene Therapies collaborating with Trades Associations to support continual improvement and innovation in the Biopharmaceutical sector. Ingrid completed her Ph.D. training at University of Wisconsin, Madison and Post-Doctoral Training at the Laboratory of Cellular and Molecular Biophysics at the National Institutes of Health, Bethesda, MD.