Basak Clements
Independent Raw Materials Expert & USP CGT Expert Committee Member Independent Expert
Basak is a seasoned biopharmaceutical development leader, driving innovation in cell and gene therapy (CGT), biologics manufacturing, and materials science. She has worked in Process Development and Materials Management roles at Amgen, Johnson and Johnson, and most recently as Global Head of Cell and Gene Therapy Materials Science at Roche/Genentech, where she implemented material sciences strategies and a risk-based material control framework for the multi-billion-dollar CGT pipeline and led global teams of scientists and engineers. Basak is an established expert in the field, member of United States Pharmacopeia CGT Expert Committee, along with other scientific advisory boards and committees shaping the evolution of advanced therapies and biologics processes, policy and standards.
Seminars
- Establishing a phase-appropriate raw material strategy that supports both early development flexibility and late-stage regulatory expectations
- Navigating evolving regulatory expectations for raw materials
- Evaluating supplier strategies, including sole vs dual sourcing, to mitigate supply chain risk while maintaining product comparability and regulatory compliance
