Melanie Tellers has over 20 years of technical and regulatory CMC experience in the development and manufacturing of biologic and cell-based products at established and emerging pharmaceutical and biotech companies. Currently, she is the Global Regulatory CMC Lead for New Products at Organon focusing on due diligence and new product development. Prior to Organon, Melanie was leading Regulatory Affairs CMC at Tmunity Therapeutics responsible for regulatory strategy and development of preclinical and clinical T-cell therapies. She has industrial experience in formulation development, in-process analytical development, and characterization at Chiron and Merck & Co. while she has extensive global regulatory CMC experience for biologic therapies from clinical development to registration at Merck & Co. and Daiichi Sankyo. She holds a B.S. in Biological Sciences from University of California Irvine.