Nicholas Schill

Dr. Schill is an experienced pharmaceutical, medical device, and combination product development professional with a passion for developing and implementing innovative solutions to complex technical, quality, and compliance challenges. His diverse background, including biopharmaceuticals and medical devices, provides a unique, holistic perspective on product development and life cycle management.

Dr. Schill’s experience includes early phase discovery, formulation, downstream process development, container closure development and validation, analytical and bio-analytical method development and validation, and preclinical development. He has experience across a wide range of therapeutic products, including blood plasma-derived therapies, recombinant novel biotherapeutics, biosimilars, small molecules, autologous cell therapies, and viral vector-based gene therapies.

Dr. Schill provides program, strategy, and technical leadership in the development of combination products and Class I/Class II medical devices, including injection, infusion, reconstitution, nasal delivery, and electromechanical devices. Dr. Schill also provides technical leadership for the development of regulatory and clinical strategies and submissions, external vendor and contract manufacturer management, process and design validation, and device labeling and instructions for use development.

Prior to joining Kymanox, Dr. Schill held positions at Shire, Baxalta, Baxter, and the University of Wisconsin. Dr. Schill holds a PhD in Cellular and Molecular Biology from the University of Wisconsin at Madison and a Bachelor of Science in Natural Sciences from Saint Norbert College where he graduated Magna Cum Laude.