Jim Weber, Head of CMC Biologics

Jim is a high-performing R&D leader with significant experience developing biologics and small molecules into successful drug candidates. An accomplished scientific leader and functional manager in areas of Analytical and Pharmaceutical Development, Jim has lead teams in the development of several new biologic and chemical entities that are now marketed drugs. He has a proven track record building and optimizing organizations, managing projects, and applying essential technologies to achieve business objectives while minimizing risk. Throughout his career, Jim has been responsible for working with multi-disciplinary teams creating pharmaceutical development and regulatory strategies for biologics (monoclonal antibodies, vaccines, bispecifics) and small molecules and has been a team leader for key initiatives across R&D and Commercial organizations (Lean Early Development and Criticality Analysis).

Prior to joining NGT, his most recent role as Senior Scientific Director, Data and Dossier Sciences for Johnson & Johnson, Janssen Pharmaceutical, showcased Jim’s ability to lead the development and execution of data science, analytics, and system strategy for the CMC organization (1500+FTE)