FARGO, N.D.--(BUSINESS WIRE)--Aldevron, the leading plasmid DNA, proteins and mRNA manufacturing company, is pleased to announce the hiring of Kenneth (Ken) Bonnell as Vice President of Quality and Regulatory Affairs.
Bonnell will join Aldevron’s executive team, and in addition to overseeing quality and regulatory compliance, will supervise standards across all Aldevron’s sites.
“Ken is a rare industry expert on biotechnology, pharmaceuticals and medical device regulatory compliance, standards, and quality assurance,” said Marc Wolff, Aldevron’s Chief Financial Officer and Chief Operating Officer. “His work ethic, team-based approach and dedication to delivering the best outcome for our clients, makes him the optimal fit on the biomanufacturing team.”
Bonnell is an accomplished quality, operations and regulatory compliance expert with more than two decades of ever-increasing experience. Most recently, he served as the Vice President and Global Head of Quality for Teligent Pharma, a multi-million-dollar global pharmaceutical company. Bonnell was responsible for returning the organization to a state of compliance after an FDA warning letter. He also spent five years at Merck as its Director of Quality Assurance, and six years at PCI Pharma as its Executive Director of QA and finally as their Global Vice-President of Quality and Regulatory Affairs.
“Aldevron has a distinguished reputation for the highest quality products and services,” said Bonnell. “I look forward to building upon and strengthening that reputation by reviewing all currently established procedures and implementing process improvements, maintaining rigorous compliance and regulatory standards, and further support our clients’ approval processes.”
He continued, “I see QA as a partnership with our clients and I look forward to putting my expertise to work to help Aldevron and its teams reach goals during a time of rapid growth.”
Bonnell graduated with a B.S. degree in Biology from Mary Washington University, Fredericksburg, V.A., and an M.B.A. in Business Management from Montgomery University, Meridian, M.S., a Master of Science in Biology from the University of Nebraska, Kearney, N.E., and he earned his Six Sigma Black Belt Certification from Villanova University, Villanova, P.A. He and his family will make their home in Fargo.
Aldevron serves the biotechnology industry with custom production of nucleic acids, proteins, and antibodies. Thousands of clients use Aldevron-produced plasmids, RNA and gene editing enzymes for projects ranging from research grade to clinical trials to commercial applications. Aldevron specializes in GMP manufacturing and is known for inventing the GMP-Source® quality system. Company headquarters are in Fargo, N.D., with additional facilities in Madison, Wisc., and Freiburg, Germany.