Chen Ding

● About 20 years of pharmaceutical industry experience in multiple areas, including- Oligonucleotide: Directed full analytical characterization for siRNA drug candidates, including those with LNP, GalNAc, and other chemical/biological modifications.- Protein/Peptide: Conducted downstream characterization of recombinant proteins, Antibody-Drug Conjugate (ADC) and Antibody-Oligonucleotide Conjugate (AOC).- Small Molecule Leadership: Served as the Functional Lead and Analytical SME for MAVYRET®, driving the program’s analytical strategy from early toxicity studies to final NDA approval.- Global SME & Compliance: Led technical transfers of analytical development to international CMOs across the US, Europe (Ireland, Italy), and Asia (China, India, Japan, Singapore). Prepared four manufacturing sites for successful Pre-Approval Inspections (PAI) by the FDA, MHRA, and TGA. Authored and addressed regulatory comments on briefing packages and NDAs.