Michael W. Vandiver
Senior Vice President, Biotherapeutic Operations
Mike has over 30 years of biopharmaceutical process development and manufacturing experience that includes 14 years at Amgen in Principal Scientist and Director level roles. Prior to Just, Mike was the Director of Pilot Plant Operations at Amgen. His responsibilities included the management and operational oversight of upstream, downstream, and plant automation/engineering activities for the pilot-scale production (2kL) of early and late stage molecules. During Mike’s tenure, plant success rates were >95% for nine consecutive years while increasing run rate, plant utilization, and decreasing headcount.
Mike was also the Technology Team Leader and an architect of Amgen’s Manufacturing of the Future (MoF) initiative that enabled highly productive and cost-effective biologics manufacturing. His team successfully identified, operationalized, and implemented disruptive technologies to a network of pilot, clinical, and commercial facilities. As a Principal Scientist, Mike managed several cross-functional first-in-human and commercial process development molecule teams, aggressively moving them towards IND filings and CMC regulatory submissions. He was also the Enbrel Upstream Scientific Lead responsible for technical activities related to process improvements, second-generation process development, characterization, validation, process transfer, and technical support for commercial production facilities. Prior to Amgen, Mike worked for 8 years at ICOS Corporation where he was accountable for managing Cell Culture and Microbial Clinical Manufacturing and Cell Culture Process Development. Early in his career, he held Production Manager and Research Associate positions at Scantibodies Laboratories and Ultra Diagnostics, respectively. Mike received his Bachelor of Science in Microbiology from the University of Washington. He is also a Registered Microbiologist (R.M.) with the American Academy of Microbiology in Research & Developmental Microbiology.