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Kenneth Miller, Ph.D.

Senior Scientist, Bioassay Development, Analytical Sciences, Biopharmaceutical Development at MedImmune

Profile

Dr. Miller is a Principal Scientist in Global Technical Operations at AstraZeneca. Ken serves as an analytical lead for late-stage and commercial projects in AZ Supply Biologics, and is responsible for providing leadership to enterprise-wide analytical activities. Ken was previously a member of the Dept. of Analytical Sciences in Biopharmaceutical Development at MedImmune. While at MedImmune, he was a champion of applying Quality by Design (QbD) approaches to bioassay method development, and was responsible for the successful delivery of the analytical sections of several first-time-in-human submissions. Since 2010, Ken has served as a member of the USP General Chapters Biological Analysis expert committee, and as a member of that committee has chaired expert panels tasked with authoring general chapters on Immunological Test Methods and Validation of Commercial Test Kits. Ken holds a Ph.D. in Biological Sciences from Carnegie Mellon University and a B.S. in Biochemistry from Case Western Reserve University.