Kim Wolfram

Director, Global Regulatory CMC Biologics & Gene Therapy
Kim Wolfram, Director in Global Regulatory Affairs CMC. ?She currently leads the biologics and gene therapy team.?Her previous regulatory experiences includes acting as a regulatory project team lead and the global regulatory lead for programs at various stages in development. ?She is committed to advancing novel manufacturing?technologies and defining the future for regulatory science.? Kim is a member of the PhRMA GQM Workgroup and is an active participant in regulatory policy development. ?She is the Global Co-Chair for ReachOUT and passionate about diversity, inclusion, and equity. Prior to Biogen, she was in Quality Assurance at Abbott Bioresearch Center (now AbbVie), where she supported the contract manufacturing for Seattle Genetics and Zymogenetics.?Kim received her Master of Science degree in Regulatory Affairs and Health Policy from the Massachusetts College of Pharmacy and Health Sciences and an undergraduate degree in Natural Sciences from Saint Anselm College.