Kevin led the development of Johnson & Johnson’s approach to identifying and assessing Drug Substance critical variability. He further deployed in their global development and operations. Since that time, he has helped many small pharmaceutical firms assess their syntheses and define their CMC control strategy. He has worked on 40+ drug substances which span the entire product lifecycle. Kevin takes a practical approach which allows scientists to assess risk with limited data sets. He is effective in facilitating team discussions to document current state product and process understanding.