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) for operational excellence.- Integrated and operated key updates in accordance with EMA Annex 1 revisions, including PUPSIT and Contamination Control Strategy (CCS).- Lead the setup and operation of an integrated electronic Quality Management System (eQMS), including eQMS, eLMS, eDMS, and LIMS.- Established the Validation Master Plan and its subordinate plans, such as Cleaning, Sterile, Computerized, Method, and Process Validation Master Plans.- Directed Business Development (BD) strategies for Contract Manufacturing Organization (CMO) services, focusing on securing potential clients and creating effective marketing strategies.- Set up a robust Supplier Quality Management system for supplier qualification and control.- Spearheaded factory automation through the implementation and management of Warehouse Management Systems (WMS), Real-Time Warehouse Systems (RWS), and SAP for seamless operations.

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, resulting in increased yield and improved efficiency.- Developed, managed, and enhanced a comprehensive training program for new production staff, focusing on building a strong Quality mindset and GMP adherence. This initiative significantly improved employees productivity and product quality.

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 troubleshooting for complex validation processes, maintaining high standards of quality and regulatory adherence.- Directed Technology Transfer (Tech Transfer) for all validation-related activities, ensuring seamless transitions and consistency in validation protocols.

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 requirements.Organized and led regular Quality meetings with over 11 major global Big Pharma clients, facilitating critical decision-making processes on quality issues.Collaborated closely with cross-functional teams, including QA, MSAT, and Production, to address major deviations, identify root causes, and implement effective corrective and preventive actions (CAPA).

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 revalidation at Plant 1 and reviewed validation and modification documents for Plant 2 and CMP Cell Culture equipment.- Change Control and Deviation Management: Managed Change Control and Deviation approvals related to validation at Plants 1, 2, and CMP for Cell Culture equipment, and for MFG and QC equipment at Plant 3.- Subject Matter Expert (SME) for Inspections: Served as the QA SME during FDA, EMA, and other regulatory inspections, providing validation expertise for capital projects and system modifications. Acted as SME for client audits and regulatory inspections, overseeing validation plans, protocols, reports, deviations, and change controls.- New Product Introduction(NPI) and Tech Transfer: Supported new product Process Performance Qualification (PPQ) and managed technical transfers for both new and existing products. Led cross-functional teams in new product validation and tech transfers for CMO products. Managed Quality Assurance tasks for NPI, PCS, and QA governance.- Leadership in Validation and Quality: Led the Validation Quality Group and Client/Product Quality Group, addressing quality issues and leading tech transfer for validation. Directed quality engineering for new Plants 2 and 3, reviewing and approving all Deviation, Change Control, and CAPA records.- CMP System Oversight: Participated in CMP Harvest area PLC system modification, reviewing and approving related documentation and change control. Managed overall quality issues related to Plant 3 validation.

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 (FAT) and Site Acceptance Testing (SAT) with the vendor.- Successfully oversaw the full implementation of Getinge’s WFI system and clean steam system, from URS development through FAT/SAT with vendor coordination.- Led revalidation efforts for the existing facility to ensure ongoing compliance with GMP standards.- Served as a Quality Assurance Specialist for biological products, particularly vaccines, with a focus on GMP inspection management (MFDS, WHO). 1) Conducted comprehensive document reviews, including SOPs, qualification and validation reports, and third-party documentation. 2) Managed self-audit processes, including follow-up on CAPAs, change controls, and deviations to ensure continuous improvement.- Acted as a Training Coordinator, delivering specialized training to inspectors from MFDS and WHO. 1) Completed a year-long advanced GMP training program under the guidance of MFDS special advisor Lee Chung-Keel.- Led performance qualification for autoclaves, optimizing the loading pattern through a bracketing design approach to increase efficiency.- Directed visual inspection process validation and inspection machine process validation for enhanced quality control.- Managed computerized system validation across key platforms, including Warehouse Management Systems (WMS), Laboratory Information Management Systems (LIMS), single-use bioreactors, freeze dryers, product facilities, and utilities.- Played a critical role in developing SOPs and executing Quality Management Reviews (QMRs) for biological products, ensuring compliance and operational excellence.

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 validation efforts for Bio-safety Level 3 (BSL-3) laboratories in collaboration with the Korea Centers for Disease Control and Prevention (KCDC), ensuring all equipment and processes met stringent biosafety standards.- Successfully passed inspections by the KCDC for BSL-3 laboratory operations, ensuring full compliance with national biosafety regulations.- Spearheaded validation projects in pharmaceutical engineering, ensuring that critical equipment and processes adhered to GMP guidelines.- Managed validation for utility and facility systems, aligning with the Ministry of Food and Drug Safety (MFDS) regulations for pharmaceutical manufacturing environments.