Emnet Yitbarek, PhD

Dr. Emnet Yitbarek is a Regulatory Staff Scientist at the FDA’s Center for Biologics Evaluation and Research (CBER). In this capacity, he performs critical regulatory reviews of submissions and conducts lot release testing using advanced physicochemical techniques to ensure the safety and efficacy of biological products. Dr. Yitbarek’s career began with a foundational B.S. in Chemistry from Addis Ababa University, followed by an M.S. from North Carolina A&T State University. After a tenure as a QC Chemist in the personal hygiene industry, he earned a Ph.D. in Analytical Chemistry from North Carolina State University. Before joining the FDA, Dr. Yitbarek held pivotal roles in both industry and government research. At Eli Lilly and Company, he specialized in high-throughput small drug mass-guided automated purification and lead identification/optimization. Later, at the National Institutes of Health (NIH), he served as an Assay Development Supervisor and Pre-formulation Staff Scientist for Biologics. Following a role as an Analytical Method Development Scientist at Novavax, Dr. Yitbarek now leverages his extensive technical background to bridge the gap between innovative drug development and complex regulatory compliance.