John Harrahy is a Director of Process Development in the Pivotal Attribute Sciences Department at Amgen Corporation in Cambridge, Massachusetts. His team supports process development from FIH through licensure, helping to characterize, define, and measure the critical quality attributes of late stage therapeutic molecules, including mAB’s, BiTE’s, synthetic modalities, viral modalities, and biosimilars. John has also worked to initiate and lead Amgen’s Analytical Target Profile workstream. Prior to joining Amgen, John worked at Genzyme/Sanofi in dual roles of CMC project management and Director of Analytical Development. He earned his PhD at Oregon State University.