Paul O'Shea, Ph.D.
Paul O’Shea has more than 25 years of multidisciplinary experience in research and development in the pharmaceutical industry. Paul began his career at generic manufacturer SIFA Fine Chemicals and then joined Merck & Co. Inc. where he held positions of increasing responsibility in Process Research. Paul served in leadership positions in Technical Operations at Merck Sharp & Dohme Ireland, as Director Process Research and Director Discovery Pharmaceutical Sciences at Merck Frosst Canada and most recently as Senior Director Analytical Chemistry and Executive Director Process & Analytical Chemistry at Merck Research Laboratories in Rahway, NJ.
Paul has significant experience in leading drug substance process development from preclinical to commercial scale and has developed synthetic routes for more than 40 NCE’s from gram and kilogram to ton scale production. He has experience working with CRO’s and CMO’s based in US, Europe and Asia and API technology transfer from lab to pilot to manufacturing scale.
Paul also has considerable expertise in the transition of programs from late stage lead optimization through to FIH clinical studies, including the development of efficient synthetic strategies for analog synthesis in support of SAR, assessment of physiochemical properties, phase and form selection and the development of formulations to support preclinical in-vivo and toxicology studies. He has also conducted numerous due diligences and technical assessments in support of licensing opportunities.
Paul earned both a BS and Ph.D. in Chemistry from University College Galway, Ireland and has coauthored 43 peer reviewed publications and 19 patents. Paul currently consults with Biotech and Pharmaceutical companies on drug discovery and development.
Paul has significant experience in leading drug substance process development from preclinical to commercial scale and has developed synthetic routes for more than 40 NCE’s from gram and kilogram to ton scale production. He has experience working with CRO’s and CMO’s based in US, Europe and Asia and API technology transfer from lab to pilot to manufacturing scale.
Paul also has considerable expertise in the transition of programs from late stage lead optimization through to FIH clinical studies, including the development of efficient synthetic strategies for analog synthesis in support of SAR, assessment of physiochemical properties, phase and form selection and the development of formulations to support preclinical in-vivo and toxicology studies. He has also conducted numerous due diligences and technical assessments in support of licensing opportunities.
Paul earned both a BS and Ph.D. in Chemistry from University College Galway, Ireland and has coauthored 43 peer reviewed publications and 19 patents. Paul currently consults with Biotech and Pharmaceutical companies on drug discovery and development.