Chloe

1. Drug Substance Quality (DSQ) Operation of P1, P2 and P3 1.1 Operator Training Revamp on Manufacturing Batch Records Training program planning, Leading training material preparation and Filming training video materials consisting of Step1 (General GMP training), Step 2 (Unit operation training and Step 3 (Product specific training) 1.2 Establishment of DSQ work instructions for the consistent and sustainable business 1.3 Trouble shooting for DSQ – FIT failure response, New creation of cell bank release procedure, DS conditional release 2. mRNA Project in P3 2.1 Participate in the mRNA new facility initiative 2.2 HR preparation for mRNA project 2.3 Regulation and Guideline Gap analysis 2.4 Leading change control of mRNA new business introduction 2.5 Scientific knowledge support 3. Multimodal plant (MMP) project for Cell & Gene Therapy (CGT) in P5 3.1 Participate in the MMP initiative 3.2 Regulation and Guideline Gap analysis 3.3 Scientific knowledge support

Area: New drug development, PROTAC Major experience: Quality Management/New Drug Operation/Business Operation 1. Set up shopMaking new R&D Facility and Office space 2. Building Digital Work Environment System introduction for digital transformation on business (Server&Network system, Collaboration tools, Communication tools, Security, ERP, ECM, Groupware, EDMS, ELN,LMS, etc.) 3. Establishment of Company Rules, Policies and Procedures 4. Data Quality Management & Improvement 5. Nonclinical CRO Pool research 6. Supplier Quality Management 7. Establishment of Target Product Profile (TPP) of new drug pipeline 8. Company Branding with the core value, mission, slogan and CI design 9. Establishment of Guideline for Company Work Environment 10. Participated in building new company culture 11. Leading the long term plan of recruitment and budget

<Professional Experience> Area : mAb Drug Substance and Drug Product (DS/DP/L&P) Major experience : Quality Assurance / Quality Audit / Regulatory Inspection Detailed experience: 1. Management, review and approval of manufacturing records - Design manufacturing records (MRs) as per GMP compliance and established procedures - Primary setup for EBR - Confirm completion of all docs and analytical requirements as described in SOPs and batch/formulation records - Review and approve MRs 2. Batch release - Generate batch disposition documents for process intermediates and Drug Substance - Compile and confirm batch disposition doc. as per MAA 3. QA oversight on the MFG site - GMP facility and utility system monitoring - Improve GMP premises as per GMP comliance 4. Validation - Review and approve val. protocols and reports - Val. strategy setup & Facility setup qualification and continuous verification of the val. status

Work for Natural Product Lab. Study about Animal Virus Diseases at veterinary college