JUNHEE KWON

1. 2.5K GMP site Set-up

- Qualification of Single Use System

- Recipe and method development of Downstream Equipment

- Tech Transfer of new project

- Project scheduling

2. Manufacturing Manager

- 2.5K Downstream Process (Chromatography, UF/DF, Single UseSystem)

- On-site supervision and management

- Employee Training

1. Qualification/Verification (SAT, IOV, PVT)
- Chromatography Skid, UF/DF Skid, Single Use System
- Small Equipment (e.g., POD holder, FIT, Utility Station)

2. 1K GMP site Readiness
- Buffer Hold Study and Product Hold Study
- Generate Process MBRs and Equipment SOPs
- Engineering Run of Downstream Process

3. Shift Leader of Downstream Process
- On-site supervision and management
- Employee Training

4. Leader of Operation Support
- Tech Transfer Support (e.g., BOM, CV, SMP, mass balance)
- Generate GMP document (e.g., MBRs, SOPs)
- QMS (e.g., Deviation, CAPA, Change Control)

5. Process Innovation Leader

- Reduce costs by discovering material suppliers ($10,000 per batch)
- Establishment of database for manufacturing consumable and raw material (approx. 1,000 EA)
- Introduction of Master Data Management (MDM)
- Internalization of maintenance (Chromatography skid, Column)