김영찬 Email & Phone Number

대한민국 인천 송도국제도시

Manufacturing Science & Technology

대한민국 서울

◼ Cell Culture Technical Support- Technical support for cell culture process to produce mAb, recombinant protein, bi-specific, CGT, AAV Vector, ADC.- Technical support for Cell line development with CHO-S, DG44, ExpiCHO-S cells.- Technical support for Hydrolysates (a.k.a. peptones).- Technical support for equipment of Cell therapy process.  - Discovering sample test opportunities and introduce the description of sample product.- Complaint reception and investigating customer deviation (with customers).◼ Training and lecture of Cell Culture Solutions- Internal training for product information, basic biology to Sales Team.- Lecture for Cell Culture Solutions and related case study to Customer.◼ Customer service- Preparing and Performing projects related to Cell Line Development and Media screening (with customers)

대한민국 인천 송도국제도시

■ Technical Transfer- Preparation of Process Characterization (PC) Study for next Project that were scheduled production for Clinical phase.- Preparation and Reviewing Process Description (PD) next Project that were scheduled production for Clinical phase.- Operation for ENG, GMP batch of 2 EA Biosimilar production.- Preparation of Trend Report for Cell Culture Parameter.- Performing PIP assignment tasks for technical transfer with a domestic CMO company.◼ Plant (1000 L Scale) Set Up- Reviewing Technical bid evaluation (TBE) for Single-use production system.- Preparing Spec. Sheet for Single-use Bioreactor, Tank, Depth Filter Skid and Lab-ware.- Reviewing Data Integrity for each equipment.- FAT, SAT and Validation for Cell Culture equipment. - Introducing Wall-to-wall system for fluid operation in Single-use System.- Introducing DS Filling system for Sterile operation in Single-use System.- Building Master Cell Bank (MCB) / Working Cell Bank (WCB) manufacturing site.◼ DS Manufacturing- Operation of Cell Thawing, Cell Expansion, Inoculation, Cultivation, Media Preparation and Harvest.- Leading of investigation for Deviation.- Leading of Change Control for DS manufacturing site, equipment, Validation status, Revision of Document.- Reviewing Process Description (PD) of each project.- Reviewing Manufacturing Batch Record (MBR) of each project.- Reviewing Standard Operation Procedure (SOP) of equipment, manufacturing procedures, maintenance and Data integrity.◼ Training- Aseptic Qualification of Gowning for Sterile area. (ISO 5 / ISO 7) from Celltrion Inc.- Aseptic Qualification of Media Filtration from Celltrion Inc.- Aseptic Qualification of Vial Frost (for Cell Thawing) from Celltrion Inc.- Aseptic Qualification of Cell Expansion from Celltrion Inc.