Brian Kelley is the Vice President of Bioprocess Development at Genentech, which is responsible for development, validation, and technology transfer of fermentation, cell culture, chromatography and filtration unit operations for the production of recombinant therapeutic proteins derived from both mammalian and bacterial hosts. Brian joined Genentech in 2007, after working 15 years at Genetics Institute (later purchased by Wyeth). From 1992-2007, he served as an adjunct faculty member of the Chemical and Biological Engineering department at Tufts University, where he taught two graduate classes each year on Principles of Cell and Microbe Cultivation, and Protein Purification. He obtained his B.S. in Chemical Engineering from the University of Wisconsin-Madison, and his Ph.D. from MIT. His interests include experimental design and other statistical methods applied to process development, filtration for cell and virus removal, ultrafiltration of high concentration protein solutions, development of novel affinity chromatography ligands for protein purification, and high throughput chromatographic development. Brian has worked extensively on Quality by Design tools and risk assessments at Genentech. Brian has been active in the American Chemical Society’s Biotechnology division, chairing sessions on biopharmaceutical process validation since 1997. Brian is a fellow of the American Institute of Medical and Biological Engineering, serves on the PDA Biotechnology Advisory Board and has chaired the Recovery of Biological Products Board.