Steven Highfill
About Steven Highfill
Steven Highfill serves as the Director of Product Development at the Center for Cellular Engineering at the National Institutes of Health, where he has worked since 2016. He specializes in ensuring compliance with FDA regulations and leads activities related to cell therapy products.
Work at National Institutes of Health
Steven Highfill has served as the Director of Product Development at the Center for Cellular Engineering within the National Institutes of Health (NIH) since 2016. In this role, he oversees the development of processes and assays for biological products, ensuring compliance with FDA regulations. He manages project plans to meet clinical manufacturing goals for NIH Clinical Center Investigational New Drug (IND) submissions, collaborating with Clinical Center Investigators and Clinical Research Managers to address project challenges.
Education and Expertise
Steven Highfill earned his Ph.D. in Microbiology, Immunology, and Cancer Biology from the University of Minnesota, where he studied under Dr. Bruce Blazar. He also completed studies at the University of South Florida. His academic background provides a strong foundation for his expertise in cellular engineering and product development in the biomedical field.
Background
Before his current position at NIH, Steven Highfill held various roles in the biomedical research field. He worked as an Investigator at Novartis Institutes for BioMedical Research from 2014 to 2015 and as a Postdoctoral Fellow at the National Cancer Institute from 2010 to 2014. His early career included a position as a Laboratory Technician at Moffitt Cancer Center from 1999 to 2004.
Achievements in Product Development
In his capacity as Director of Product Development, Steven Highfill leads Chemistry, Manufacturing, and Controls (CMC) activities for new cell therapy products at the Center for Cellular Engineering. He is responsible for authoring CMC sections for IND submissions, which are critical for supporting clinical trials. His efforts contribute to advancing the development of innovative therapies in the field of oncology.