Stephen M. Perry

Stephen M. Perry has over two decades of experience in biopharmaceutical manufacturing with an emphasis on design engineering, scale-up, start-up, and regulatory approval. Stephen has participated in the FDA commercial approval of more than two dozen unique drugs, devices, biologics, and combination products. He has extensive cGMP experience as a Process Engineer, Technical Project Manager, Quality Manager, Regulatory Auditor, and Information Technology Strategist. His work with novel cancer drugs, including autologous cell and gene therapies, and next generation antibiotics are notable from a technology transfer perspective. Stephen has led numerous multi-million-dollar capital projects and has contributed to several major facility installations and qualifications, which began at the conceptual design phase.

In 2004, Stephen created Kymanox as a professional services firm specializing in commercializing modern medicine. Starting with a small investment and large commitment, Stephen has strategically grown Kymanox into a nationally recognized organization serving companies in combination products, biotechnology, pharmaceuticals, and beyond. Prior to Kymanox, Stephen had various leadership roles supporting commercialization at M+W Group, Abbott Laboratories, FujiFilm Diosynth Biotechnologies, and Human Genome Sciences.

Stephen is a keynote speaker at life sciences conferences and author for industry publications. He advises several companies at the C-suite level and has served on the board of directors of publicly traded companies. Stephen is an industry-recognized expert in several subject areas, including technology transfer and scale-up. Stephen is a long-time supporter of the Regulatory Affairs Professional Society (RAPS), International Society of Pharmaceutical Engineering (ISPE), Parental Drug Association (PDA), and the Project Management Institute (PMI). He graduated with high honors with a bachelor’s degree in Chemical Engineering from the University of Notre Dame and studied at the graduate level at Purdue University.