Work Experiencesas Process Expert and CMC Reg. skilled person[CMC Regulatory]- IMPD/CTD documentation (CMC)- Biological products targeted for BLA- CMC review as regulatory perspectives- Communication skill w/SME and/or partners- Review/Management in overall CMC events- Change control/version track per the HA interactions[Research & Development Expert]I. DS/DP Process Development in R&D- Protein-based formulation development- Process development/optimization study- Feasibility/Comparability test- E&L study protocol support & follow-up- Extension shelf life of DP- Container Closure System (combination product for NDA in compliance with US Regulation)- Clinical trial material support (Tech transfer, Manufacturing & Shipment management)- Clinical Phase 1,2 IND approvalII. Downstream Process (DSP) for drug substance- TFF utilization / Process devleopment- Robustness study by DoE