| Lee is a Scientific Leader in the Biopharm Drug Substance Process Development organization at GlaxoSmithKline. He has over 18 years of experience in process development and scale-up, internal and external tech transfers, and has led or supported several Process Performance Qualification campaigns. In addition, he has authored a number of regulatory submissions, several of which involved an assessment and documentation of Established Conditions, per ICHQ12. He is the R&D lead for the Biopharm QbD and Control Strategy team at GSK and has led or contributed to many aspects of the QbD and Acceleration strategy at GSK. |
