San Francisco Bay Area
Strategic healthcare professional and licensed pharmacist with over five years of experience in the South Korean biotech sector, specializing in the intersection of clinical science and global commercial operations. Proven track record at Celltrion in identifying and evaluating high-growth immunology assets and platforms to drive portfolio expansion. Expertise centers on scientific due diligence and business development, with four years focused on global immunology market trends and the technical evaluation of next-generation modalities, including bispecifics, Fc-engineering, and ADCs. Contributed to the strategic launch of Zymfentra (SC infliximab) in the U.S. market and represented the firm in global investment meetings and scientific conferences. Backed by a 6-month rotation in pharmacovigilance, bringing a practical understanding of the intersection of clinical science and commercial operations.
- Developed and implemented RMPs, ensuring robust safety specifications and risk minimization across product lifecycles - Led systematic signal detection and risk-benefit analyses - Managed and submitted safety reports to global and local health authorities, maintaining strict regulatory compliance
- Analyzed global immunology market trends and pipeline developments (IBD, RA, etc.) - Assessed immunology pipelines and platform technologies (e.g., bispecifics, Fc-engineering, ADCs) - Represented the company in investment meetings with global biotechs and synthesized key insights from major international scientific conferences. - Served on Celltrion’s task force team for the U.S. launch of Zymfentra (SC infliximab), contributing to market readiness and strategic planning
- Ensured all drug products met registered specifications and complied with local/international regulations prior to market release - Conducted gap assessments of QM and GOPs and implemented streamlined development standard - Managed the lifecycle of Standard Operating Procedures to ensure strict adherence to cGMP/GDP regulations and corporate quality manuals