At Samsung Biologics and GSK, I lead CMC product lifecycle strategy, regulatory submissions, PPQ readiness, and technical execution for commercial biologics including Benlysta, Nucala, Blenrep, and Retacrit. I’ve authored and reviewed Module 3 CMC content, led responses to Health Authority Questions, and supported inspections with no findings in my assigned areas.
I translate complex manufacturing and quality risks into durable process controls, validation plans, and change strategies. My work has delivered more than 5% yield improvement and over $147K in cost savings per batch, maintained 100% downstream batch success across campaigns, and strengthened site-wide change-control quality processes.
