Kurt Brorson

Kurt Brorson

Vice President, Technical
PAREXEL Consulting

Kurt Brorson, Ph.D. is Vice President, Technical, at PAREXEL Consulting where he provides a full range of consulting services for the quality of biopharmaceuticals, with specific expertise in biomanufacturing, therapeutic monoclonal antibodies, biosimilars and viral safety/viral clearance.  He also acts as a trusted advisor to clients, often on issues that lack precedent or are not clearly defined.

Prior to joining PAREXEL, Dr. Brorson was a Lab Chief in CDER/OPQ/Office of Biotechnology Products (OBP) at the FDA.  Dr. Brorson received his BA. in Biology from University of Chicago (Chicago IL) in 1984 and Ph.D. in Molecular Biology from California Institute of Technology (Pasadena CA) in 1990.   Dr. Brorson’s 26 years’ experience with FDA including CMC review, facility assessment & compliance (including pre-approval inspections) for BLAs, DMFs, and INDs.  He also managed a highly productive and well-respected lab-based program project focused on viral safety of biotechnology medicinal products.   He assisted external organizations like PDA and ACS BIOT in conference planning and writing of technical reports on highly specialized topics germane to bioprocessing and biopharmaceuticals.  He is widely considered to be a world-class expert in viral clearance during bioprocessing and viral safety of biopharmaceuticals.