David Bradshaw, President

David Bradshaw is an accomplished Pharmaceutical Operations Executive with over 35+ years of extensive experience in process development, equipment and process validation, scale-up, tech/site transfer, distribution, and successful launch of numerous commercial products across start-up operations and established organizations.

Most recently, Dave spent over seven years at Harmony Biosciences, an innovative biotech company with a market cap of approximately $2 billion focused on rare neurological diseases, where he served as Senior Vice President of CMC and Technical Operations (including Quality Assurance). Prior to Harmony, he started his career in large Pharma working at Sandoz (now Novartis) and Organon before transitioning into virtual, start-up companies including PathoGenesis, Biomira, Ovation, and Marathon, where he served as Head of Manufacturing for each entity.

As a result of his successful three decades plus of work leading manufacturing at small and large Pharma and Biotech companies, Dave brings significant depth and breadth of Pharmaceutical Operations experience and knowledge with him including supply chain/production planning, management of production at CMO/CDMOs, third-party logistics (3PLs), and various analytical testing facilities for development, clinical, and commercial products. He has experience working with multiple dosage forms including solid and liquid oral, solutions for inhalation, and liquid, lyophilized, and powder for reconstitution small volume parenterals, with a product mix of primarily small molecule products and several biologic products.

Dave has led the negotiation, initiation, and management of Supply and Quality Agreements. He has implemented and/or improved Quality Systems for compliant operations at multiple companies and has experience with regulatory pre-approval and general inspections (FDA and EU), and remediation activities related to the CDMO activities and NDA submissions. Dave also has extensive experience in due diligence activities for product and company acquisitions and divestitures, including the successful integration of products and personnel following acquisition.

Dave holds a Bachelor’s Degree in Chemistry from Fairleigh Dickinson and has completed coursework toward an M.S. in Regulatory Affairs from the University of Florida College of Pharmacy.