Technical Operation Team(Purification)

Drug substance manufacturing(Purification)1. Experience in purchasing purification production equipment, conducting FAT, and On-site Validation: Introduction of chromatography skid(Bioprocess Modular), columns, floor scales, bag testers, and 1500kg pallet tanks.2. Experience in CMO product manufacturing, PIP compliance, and deviation management.3. Experience in internal audits and external audits by regulatory bodies (FDA, EMA, KFDA).4. Experience in in-house DS product manufacturing, deviation investigation and CAPA implementation.5. Experience in initiating change control for production site improvements.6. Experience in SOP and manufacturing record revising and reviewing.

Performing process improvement tasks from the perspectives of Productivity, Quality, Cost, Delivery.