Shawn Stephens

Shawn helps pharmaceutical clients develop, scale, and launch products from the bench to FDA approval and commercial manufacturing. Drawing on two decades of cGMP experience, he solves complex process challenges involving transdermal matrix patches, topical solutions and creams, ophthalmic products, and other combination and drug-delivery systems.

Throughout his career, Shawn has led process design, validation, and technology transfer from laboratory and pilot scale to commercial production. He works across functions and with regulatory agencies, including the FDA, DEA, and Office of Generic Drugs, to help clients align product and process requirements and support efficient, compliant paths to market. He also manages multi-product portfolios and leads teams across engineering, procurement, document control, and training.