Versatile executive with 25+ years of experience in Pharmaceutical Product and Process Development and Commercialization, Commercial Supply Chain, Project Management and Team Leadership, Product Planning, Operations, Contract Site Management, Formulations, and Quality Assurance and Quality Control.Successful leader of high impact, cross-functional teams in top priority product development, process design and optimization, technology transfer, FDA regulatory filings, and drug substance and drug product commercial manufacturing.Extensive experience in small molecule solid oral modified release dosage forms, Quality by Design, cGMPs, FDA regulations, ICH guidelines, CMC source reports and NDA/ANDA/other Regulatory dossiers. Adaptable team player with outstanding skills in organizational leadership, communications, and strategic business relationships. Highly experienced in a CDMO setting as well as a sponsor selecting and managing contract service providers for development or commercial pharmaceutical products.