Jong Ho Lee

Background

About Jong Ho Lee

I am a process developer with extensive experience in technology transfer and the manufacturing of APIs (Active Pharmaceutical Ingredients). Since joining GC Pharma Corporation in October 2015 as part of the purification process team, I have been actively involved in the development of drug candidates, focusing on refining and optimizing production processes. Work Experience:My work within the process team primarily focuses on three key areas:API Manufacturing ProcessIn the API manufacturing process, I have contributed to developing culture systems, purification technologies, and analytical methods necessary for API production. I was responsible for executing UF/DF (Ultrafiltration/Diafiltration) and chromatography processes. Additionally, I developed processes by conducting screening and purification condition studies, incorporating DoE (Design of Experiments)-based approaches. I collaborated closely with the analytical team to select and apply test methods for analyzing in-process materials. Furthermore, I gained expertise in techniques for cell collection/removal and cell disruption/lysis from a process development perspective. Using the gathered data, I proposed and implemented appropriate methods for the target materials.Feasibility EvaluationIn feasibility evaluation, I assessed the potential for developing candidate drug substances by evaluating key factors such as efficacy, yield, purity, cost-effectiveness, and the need for future device investments. My efforts contributed to the submission of process patents, which improved the research institute's technology and shortened the process development timeline.Purification Development DocumentationI have authored purification process documents for CMC (Chemistry, Manufacturing, and Controls) and technical transfers. My key responsibilities included executing UF/DF, chromatography, and developing SOPs (Standard Operating Procedures) for in-process material analysis. Additionally, I contributed to regulatory submissions by supplementing the necessary supporting data.Vision and Career Goals:My goal is to address the limitations in API manufacturing processes and establish a new paradigm for manufacturing platforms. To achieve this, I aspire to lead advancements in vaccine production processes and technology transfers, leveraging my expertise in both technology transfer and feasibility evaluation. Moreover, I am dedicated to ensuring full compliance with regulatory requirements while maintaining a deep understanding of drug approval regulations and processes.