Sungwon Lee

Background

About Sungwon Lee

A results-driven Technical Group Leader and Bioanalytical Chemist with extensive expertise in industrial biotechnology, bioanalytical chemistry, product development and manufacturing. Skilled in collaborating within team-based environments and engaging with colleagues across diverse disciplines. Technical expertise includes: • Strategic Leadership: Established and led analytical teams for R&D programs and production with a focus on small molecule and protein based product discovery, development, manufacturing, regulatory submissions, and commercialization. • Chemical and Product Characterization: Coordinated diverse chemical testing for commercial target products, including chemicals and biomaterials, for characterization, evaluation, and regulatory compliance. • Analytical Expertise: Extensive experience in method development, validation, and data interpretation utilizing a wide range of analytical instruments, including GC, GC-MS, HPLC, LC-MS, ICP, FPLC, YSI, UV-Vis, FT-IR, fluorescence spectrometry, plate readers, AKTA, LECO protein analyzer, and NMR. • Project & Team Management: Experienced in hiring, training, and managing cross-functional teams, including internal personnel, contractors, CROs, and CMOs, to execute product development and manufacturing. Successfully managed multiple concurrent analytical projects in matrixed environments, ensuring timely delivery of results while maintaining high-quality standards. • Collaboration: Demonstrated success in collaborating with cross-functional teams, including R&D, engineering, regulatory, QA/QC, PMO, clinical, business, and marketing groups to drive project alignment and achieve organizational goals. • Operational Excellence: Expertise in laboratory setup and support, including design, instrument selection, method transfer, SOP development, and team training. • Global Operations: Managed bioanalytical resources across multiple locations (US, Europe, Asia) while overseeing external collaborations with academia, industry, and CRO partners. • Innovative Research: Extensive experience in protein biochemistry, with expertise in designing and implementing low- and high-throughput biochemical assays in industrial environments.