Description
Experienced with cGMP, ICH and regulatory guidelines for Drug Substance * Prepared Drug Substance CMC sections for multiple regulatory submissions. * Proven ability to work independently and as a member of a multi-disciplinary team. * Technology transfer SUPPORTED ANALYTICAL METHODS: Chromatography: Column, Thin Layer, GC, HPLC/UPLC, prep. HPLC Spectroscopy: FT-IR, NMR, LC/MS, and UV