Kathleen Retterson

SVP, CMC Biologics

REGULATORY AFFAIRS PRACTICE

Kathleen has more than 30 years’ experience in the biologics industry. Kathleen has served as site head and general manager at Amgen, Genzyme, and Charles River, where she oversaw manufacturing, QA, QC, process development, and supply chain. The majority of her professional career was spent at Amgen. Over the course of her tenure at Amgen, Kathleen held a variety of positions of increasing responsibility, including VP / GM of Amgen’s Rhode Island Facility and Site Head of Amgen’s multi-plant Thousand Oaks manufacturing site.

Over her career, Kathleen has been responsible for the successful manufacture of a number of top biologics including EPOGEN®, Neupogen®, Aranesp®, Neulasta®, Infergen®, Enbrel®, Cerazyme®, Fabrazyme® and Myozyme®.

Kathleen was a founding member of Amgen’s Sales and Marketing Department where she served as EPOGEN® product manager during the product’s first three years, and where she led the team that secured the first-ever Medicare reimbursement for a biologic. Kathleen also served as Controller for Amgen’s Operations and Capital Investments groups for two years.

Kathleen holds an undergraduate degree from Brown University, and a Master’s degree from Stanford University.

Ready for regulatory clarity? Contact us.