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