• Ph.D. in Biochemistry from the University of Connecticut Health Center • 18 years of experience in the biotech industry with Bristol-Myers Squibb Co. (2004 through 2011) and Amgen, Inc. (2011 through present) • Relevant experience: o ICH Q12 implementation team leader at Amgen Inc. with responsibilities including coordination with functional area experts on strategy and process for leveraging ICH Q12 concepts o Product Quality Director with experience in product/process characterization, stability, comparability, in-process controls and specifications o Extensive clinical/commercial regulatory experience |