Senior Research Scientist
US Food and Drug Administration
Dr. Berilla obtained her B.S. in Biochemistry from Lehigh University and Ph.D. in Biomedical Sciences from the University of South Florida. She started her FDA career in 2015 as an ORISE fellow in OPQ’s Office of Testing and Research’s biotechnology group. In 2016, she moved to OPQ’s Office of Biotechnology Products where she led the cell culture team of the upstream bioprocessing laboratory and performed primary CMC assessment for OBP products. She now works in the newly formed Office of Pharmaceutical Quality Research (OPQR) continuing as the lead of the cell culture team in the upstream bioprocessing laboratory. Her research has focused on continuous biomanufacturing, emerging upstream biomanufacturing technologies and effects of upstream process changes on critical quality attributes of monoclonal antibodies.