Jim Weber, PhD — Biologic CMC and Digital Innovation
Jim is a high-performing R&D leader with significant experience developing biologics and small molecules into successful drug candidates. As an accomplished scientific leader and functional manager in areas of Analytical and Pharmaceutical Development, Jim has led teams in the development of several new biologic and chemical entities that are now marketed drugs. He has a proven track record of building and optimizing organizations, managing cross-functional projects, and applying essential technologies and data strategies 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, including leading the development & execution of data & dossier sciences system strategies, for biologics (monoclonal antibodies, vaccines, bispecifics) and small molecules and he has been a team leader for key initiatives across R&D and Commercial organizations (Lean Early Development, Criticality Analysis, and Data Sciences projects).
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)
Expertise
- Pharmaceutical Science / Formulation Development: Scientific / Functional manager in API development, drug product development, analytical development, and drug characterization in biologics (monoclonal antibodies, duobodies (bispecifics), and vaccines) and small molecule organic chemistry.
- Regulatory: Significant experience in regulatory filings across all development phases (Early to Late); 14+ Global Product Filings (BLAs and NDAs); 100+ MAA and IDB/IND Filings. Technical review and approval of regulatory filings in all stages of development.
- Data Analytics and Dossier Sciences: Led the development and execution of a $25M cyberinfrastructure and data science plan across multiple global biologics and small molecule development organizations within a large Pharma company which included cyber-infrastructure/systems, e-reporting, data analytics, and modeling.
- New Product Development: Transform molecules into medicine with extensive experience in Analytical and Pharmaceutical Development from early development to regulatory filings, including subcutaneous, i.v. and solid dose formulations.
