JobMesh

Drug Substance Development and Manufacturing Manager

Novo Nordisk · Boulder, Colorado, US

About the Department The Boulder Site is home to the specialized technical operations/CMC team for oligonucleotides and RNAi therapeutics.

Job description

About the Department The Boulder Site is home to the specialized technical operations/CMC team for oligonucleotides and RNAi therapeutics. The CMC team works alongside Quality, Regulatory, Technical Operations and RNAi Early Development professionals at our Boulder, Colorado facility and works closely with our teams in Lexington, Massachusetts. Together, we are driving change. Are you ready to make a difference. The Position: This position is an experienced professional with the ability to support process establishment and manufacturing activities for Novo Nordisk’s oligonucleotide investigational product pipeline. This individual will be responsible for drug substance manufacturing and development at Commercial Manufacturing Organizations (CMO's) and Novo Nordisk internal manufacturing sites. Relationships: This position reports to the Associate Director of Drug Substance Development and Manufacturing. This position interacts with QA, QC, Internal Chemical Development, Drug Product Manufacturing, Program Management, CMC Regulatory, Manufacturing Operations, and Contract Manufacturing Organizations. This role is based in Boulder, CO Essential Functions: - Support establishment and...