Kyle McElearney is a Director Process Development in the Pivotal Drug Substance Biologics organization at Amgen’s Thousand Oaks, CA site. He leads an organization of ~30 staff across the Thousand Oaks campus and Cambridge, MA site. His organization is responsible for late-stage process development including commercial process development and process characterization for cell culture and downstream processes. His team is also responsible for commercialization of these biologics including authoring of regulatory documents and life cycle management. In addition, the team drives innovation for process intensification to improve manufacturing productivity ensuring high quality medicines for our patients. Prior to joining Amgen in 2017, he spent 10 years in the Cell Culture Development group at Biogen. He earned his BS in Chemical Engineering from Worcester Polytechnic Institute, and MS in both Chemical Engineering and Engineering Management from Tufts University.