Senior Scientist
CurrentCDO R&D, Analytics group,- CMC part (~Feb.2022)- complex Ab analysis part[Project Management in CMC]- Project SME(subject matter expert) in analytics group: communication and project management. qualification, product characterization, stability test and CTD preparation in nGMP stage for IND filing.- Policy and procedural document(SOPs) coordination for CMC.[Technical Experience]- Structural analysis mainly using LC/MS and UPLC.- Method development and optimization for IgG and Fc fusion protein analysis.- Tech. Transfer between CDO and small scale CMO.- Stability study for nGMP material.- Characterization study for IND filing.- Capable of following analysis;(1)Primary structure analysis; peptide mapping, intact mass analysis(including native intact mass analysis), full-length amino acid sequencing(2)N-glycan (glycosylation site, profile and structure) analysis(3)High-order structure analysis; disulfide bond analysis, CD, DSC, and SEC-MALS.