Patrick Swann

Patrick Swann is Vice President of Quality Sciences and Technology (QS&T) at Amgen. QS&T encompasses multiple Quality functions including oversight of commercial specifications, stability programs, comparability strategy, annual product review, data sciences, nonconformance investigations, inspection preparation and Quality Control/Assurance for clinical and commercial products produced at Amgen’s Thousand Oaks facility. Previously, he held positions at Biogen including leadership of the Global Regulatory CMC group and the Analytical Development group. Prior to joining industry, Patrick served for 15 years at the U.S. FDA including roles as the Deputy Director of the Division of Monoclonal Antibodies and deputy topic lead for FDA on the ICH Q11 Expert Working Group. He obtained his Ph.D. in pharmacology from the University of Illinois at Chicago. He has presented at numerous international conferences on topics including Quality by Design, process validation, and bioanalytical method development/validation.