Expertise:    New product development and life cycle management – CMC R&D for  protein therapeutics, small molecules and devices. Analytical method  development and validation. Impurity controls  (small molecules/proteins).  Formulation for protein pharmaceuticals.   Container extractable/leachable study development.  Polymer synthesis  and scale-up. Characterization of cell banks. Development of protein  expression systems. Problem solving.

Experience:    Headed research/development departments at Baxter and Abbott Laboratories.

Other:   Visiting Scholar, University of Illinois Urbana-Champaign, member of  American Chemical Society, American Society for Biochemistry and  Molecular Biology, American Association of Pharmaceutical Scientists,  CASSS, and currently serves as co-chair of the WCBP (Well Characterized  Biopharmaceutical) conference.