Maria Cecilia Tami

Maria Cecilia Tami currently serves as Head of US CMC Regulatory Policy at Genentech since April 2020. Previously, Tami held various roles at the FDA from 2001 to 2020, including Acting Review Chief, Product Quality Team Leader, and Product Quality Reviewer. Tami's expertise encompasses the evaluation of chemistry, manufacturing, and controls for biologics, overseeing review staff, and managing regulatory projects. Tami's career began as a Postdoctoral Fellow at the FDA, conducting research on viral receptors, following a tenure as a Staff Scientist at Instituto Nacional de Tecnologia Agropeacuaria, focusing on recombinant vaccines. Tami holds a PhD in Molecular Virology and a Licenciada (MS) in Molecular Biology and Biotechnology from the University of Buenos Aires. Additionally, Tami is a PTA member at Escuela Argentina Washington DC.