Hojin Lee Email & Phone Number

경기도 화성

- Lead the construction and system development of a Bio Plant, handling troubleshooting and high-level decision-making.- Successfully oversight project timelines to meet plant completion and system setup within 18 months.- Implemented and managed a cGMP-level Quality Management System (QMS).

대한민국 경기도 화성시

General Manager of Biologics Manufacutring Center

대한민국 인천 송도국제도시

Led Facility Readiness and Process Optimization at Plant 4- Spearheaded the review, approval, and completion of Plant 4 Facility Readiness, ensuring timely production startup by accelerating project timelines.- Executed cell culture manufacturing readiness and troubleshooting at Plant 4, optimizing processes to resolve issues from previous plants.

대한민국 인천 송도국제도시

Oversight of Validation Activities for Drug Substance, Drug Product, QC, Material Management, Utility & Facility- Provided comprehensive oversight of validation activities, ensuring compliance and operational excellence across Drug Substance, Drug Product, Quality Control (QC), Material Management, and Utility & Facility sectors.- Led issue resolution and.

대한민국 인천 송도국제도시

Key Responsibilities and Achievements:Actively communicated with clients on quality-related matters and reviewed/approved high-level documents associated with technology transfers, ensuring seamless execution and compliance.Prepared and conducted Due Diligence (DD) for potential clients, demonstrating deep understanding of operational and regulatory.

대한민국 인천 송도국제도시

Lead of Quality Engineering- Plant Design and Equipment Validation: Led the design and validation of new plants (P2, P3), covering Upstream and Downstream Processing (USP/DSP) equipment, URS, FAT, SAT, IOQ, and PQ. Reviewed and approved validation documents for Plant 2 USP/DSP equipment and managed the full process from URS to PQ. Led MFG Cell Culture.

대한민국 경상북도 안동시

• Lead Validation Specialist, Vaccine Plant- Spearheaded the qualification process for GEA's centrifugal separator, managing the entire process from User Requirement Specification (URS) to Factory Acceptance Testing.

대한민국 경기도 용인

Validation Manager, Validation Management Department- Oversaw the comprehensive documentation for the Quality Management System (QMS), ensuring regulatory compliance and operational excellence.- Acted as a subject matter expert in the validation of aseptic equipment, providing leadership in the development and execution of validation protocols.- Led the.