Vice President, Quality
Ken Bonnell comes to us with 25 years of Quality related experience in pharmaceuticals, biotechnology, and medical device manufacturing. He has held positions in both Quality Assurance and Quality Control throughout his career where he was responsible for various regulatory filings and submissions, interacting with multiple domestic and international regulatory authorities, and for supporting quality operations, validation, metrology, microbiology, vendor inspection and management, internal and external auditing, analytical testing, deviation and customer complaint investigation and remediation, CAPA management, environmental monitoring, sterile manufacturing, and packaging.
Ken was most recently the Global Vice-President of Quality, Regulatory, and Compliance for PCI Pharma Services, LLC where he was accountable for all Quality related functions related to their commercial, clinical, and manufacturing divisions. Prior to this role, he worked for the bacterial and viral vaccine division of Merck, Inc. located in West Point, PA, where he managed the Laboratory and Quality Operations for four different focus factories including Gardasil® and Pneumovax 23®.
Ken holds a B.S. in Biology, a M.B.A. in business management, and a M.S. in Biology. In addition, he also has earned a Lean Six Sigma Black Belt certification from Villanova, which he has used to led many process and cost savings improvement initiatives including several that have enhanced batch record accuracy and overall manufacturing cycle times.