Ligang Zhang
Vice President, DS Process Development, CMC Development @ Alnylam Pharmaceuticals
About
Highly motivated biotech leader with a passion for oligonucleotide chemistry and drug development. Expertise in API manufacturing process development, optimization, scale-up, as well as process characterization and validation. Broad experience spanning from research to development. Demonstrated record of working with various EA and program teams in bringing early development candidates (DC) into late stage development (Phase 3 and beyond).
United States
Cambridge
Biotechnology
siRNA, Drug Discovery, RNAi
Experience

Director, Process Sciences
Responsible for DS manufacturing process development and leading CMC teams in process development, analytical development, technology transfer, API manufacturing and supply to enable clinical trials application and bring DC through various of drug development. • Leading Process development, optimization and scale up. Managing manufacturing of oligonucleotide APIs in non-GMP environment • Leading DS manufacture process Transfer of to CMOs. Providing technical support and trouble shoot for GMP manufacturing at CMOs • Leading multiple cross-functional Chemistry, Manufacturing, and Controls (CMC) Team(s) for early stage siRNA drug development. Serving as the primary liaison between the Program Core Team and the CMC Team. • Leading and working with CMOs on process scale-up and characterization, Supporting process validation activities at CMOs • Supporting regulatory filings: Authoring and reviewing Quality section for CTA/IND filings. • Managing and mentoring a group of 15 scientists of various levels
Ligang Zhang's Contact Information
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