Provide guidance for the development and implementation of pharmaceutical development and manufacturing strategies for biologicals produced by recombinant DNA technology that lead to clinical proof-of-concept and commercial registration. Areas of specific expertise include:
- Process Sciences, Formulation Development and Analytical Development/Testing
- Drug Product Development
- Technical Transfer for Clinical/Commercial Drug Substance and Drug Product Manufacturing
- Process Validation, GMP Manufacturing of Drug Substance and Drug Product
- CMO/CRO Identification/Selection and Management
- Requirements for Biosimilar Development, Comparability and Registration
- CMC Program Management.
- Preparation and Review of Technical Reports and CMC Regulatory Documents
- In-Licensing/Asset and Company Acquisitions/Alliance Management
