Our Leadership Team
Stephen M. Perry
CEO and Founder
Stephen M. Perry is the founder of Kymanox – a diversified company specializing in technical project management for the Pharmaceutical, Biotechnology and Medical Device industries – as well as Sustainability and Nanotechnology. Stephen has extensive cGMP experience as a Process Engineer, Technical Project Manager, Quality Manager, Regulatory Auditor, and Information Technology Strategist. He has hired over 300 professionals in his career and currently oversees a team of more than 100.
Before starting Kymanox in 2004, Stephen had various leadership roles supporting scale-up, start-up, and commercialization initiatives at Abbott Laboratories, FujiFilm Diosynth Biotechnologies, and Human Genome Sciences.
During his career, Stephen participated with increasing responsibilities in the FDA commercial approval of 15 unique drugs, devices, biologics, and combination products. Stephen’s 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. Stephen has also designed two novel equipment systems related to virus filtration which included full automation.
Stephen has experience supporting quality assurance and regulatory initiatives related to medical devices and combination products, including successful filings and responses to FDA. Stephen is an industry-recognized instructor and author in several subject areas, including technology transfer, and speaks regularly at industry events throughout the world. Stephen has conducted and supervised more than 100 audits around the globe for supplier quality, mock PAIs, and quality management system optimization.
Stephen has a liberal education background with a high-honors bachelor’s degree in Chemical Engineering from the University of Notre Dame and studied at the graduate level at Purdue University. 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).