Shanghai, China
CMC Small Molecule Team lead. Regulatory CMC leadership and support to new product development (CTA, NDA) and marketed products (post approval filings) in China.
Lead formulation activities of the local R&D projects.
Formulation, characterisation and outsourcing management of discovery and clinical NCE projects.
Physical project lead on late phase respiratory NCE projects.
Technical support to full-scale GMP tablet manufacturing operations, including trouble shooting, product transfer & PAT (process analytical technologies) evaluations.