Trevor Lewis, PhD brings over 35 years of experience in the pharmaceutical and biopharmaceutical industries, with extensive expertise in the Contract Development and Manufacturing Organization (CDMO) space. Throughout his career, he has held senior technical and leadership positions at Abbott Labs (HPD), Cardinal Health, Catalent, Pharma Solutions, Mitsubishi Chemical Holdings, and Formulated Solutions. He has also served as a trusted principal consultant to leading biopharmaceutical, API, and pharmaceutical organizations.
Trevor earned a B.S. in Biochemistry from Andrews University, an M.S. in Analytical Chemistry from Indiana State University, and a Ph.D. in Analytical Chemistry from the University of Cincinnati. His strong scientific foundation is complemented by his extensive operational and leadership experience.
In addition to his technical expertise, Trevor has served as an Operational Excellence (OPEX) leader, business coach, and talent development strategist, helping organizations improve performance, drive revenue growth, and achieve profitability. He has broad regulatory and compliance expertise, having served as Senior Vice President of Quality and Regulatory across multiple organizations. In this capacity, he successfully remediated companies facing FDA warning letters, Official Action Indicated (OAI) designations, and Chemistry, Manufacturing, and Controls (CMC) compliance issues.
Trevor has demonstrated proven leadership in building and transforming laboratories into recognized centers of excellence, strengthening compounding and operations departments, and driving continuous improvement across Quality Management Systems (QMS). His career highlights include leading organizations through inspection readiness, instilling a culture of compliance, and implementing sustainable quality improvements that meet and exceed regulatory standards.
