Senior biopharmaceutical manager with extensive experience in the development of biological products. Demonstrates proven expertise across diverse biopharmaceutical disciplines, including regulatory experience in authoring CMC sections for clinical trials and commercial registrations.
Skills include:
- Biologics process development
- Formulation development , biologics
- cGMP manufacturing
- Authoring regulatory CMC dossiers
- Characterisation of biological products
- Technology Transfer
- Problem solving
- Managing CMOs
