Douglas Nesta, PhD — Chemistry, Manufacturing & Controls (CMC)

A biopharmaceutical CMC consultant with over 35 years of pharma industry experience, Douglas Nesta’s expertise spans discovery, process, and product development, with skills in strategic and tactical project and team leadership.

Dr. Nesta has authored numerous regulatory submissions and approvals, such as clinical and commercial development of protein and peptide products across a broad spectrum of therapeutic areas, due diligence and technical evaluations, and strategic innovation. He has also worked with leadership of global teams and third‐party development projects (US/EU/Asia); industry/university/regulatory alliances and collaborations; and partnered with external organizations (e.g., NIIMBL, Delaware Biotech Inst., NASA, NIST). 

Prior to beginning his consultancy work, Doug had a successful career within the biopharma industry, having joined SmithKline Beecham (now GSK) in 1995 and growing his responsibilities to ultimately leading the global Biopharmaceutical Product Sciences department within GSK R&D’s Biopharmaceutical Process and Product Development organization.  Prior to joining SB, Doug began his industry career as a biopharmaceutical product and process development scientist within American Cyanamid Company’s Medical Research Division.  He earned his Ph.D. (Environmental Health Sciences) and MS (Biology) degrees from New York University, and his BA (Biology) from Rutgers University.