Shawn Stephens

Background

About Shawn Stephens

Confident and strategic leader with over 19 years of specialized experience in cGMP pharmaceutical product development, manufacturing, and commercialization. Currently driving Business Development in the Pharmaceutical space for Barr Engineering. Actively scouting, evaluating, and securing high-value strategic alliances with growing pharma facilities. My core expertise is in translating scientific innovation into commercial reality. I have personally directed the process development and successful commercial launch of six pharmaceutical products, including complex transdermal patches and topical solutions, ensuring full compliance with ISO 9001 and cGMP standards while working directly with regulatory bodies like the FDA and DEA.My background spans the entire product lifecycle, from initial concept and Design of Experiments (DOE) to technology transfer (MS & T), manufacturing scale-up, and supply chain optimization. I excel at complex project management, having successfully led large cross-functional engineering teams, spearheaded SAP transitions for operations, and presented technologies to industry experts, academic institutions, and FDA/OGD personnel.Key Strengths: Business Development & Alliance Management, CMC Project Leadership, Process Development & Validation, Regulatory Compliance (cGMP/FDA/DEA), Complex Data Analysis, and Technical Mentorship.