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Senior Manager, Drug Product Manufacturing & Development

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: Novo Nordisk CMC Boulder division is seeking a highly experienced and dynamic professional to manage parenteral drug product manufacturing, and corresponding CMC regulatory activities. The Senior Manager, Drug Product Manufacturing and Development is accountable for clinical drug product manufacturing and will have thorough knowledge of cGMP's for aseptic pharmaceutical products. Frequent cross functional interaction with multiple departments will be required while supporting multiple projects. The position will work with CMO's to ensure the continuous supply of product and apply risk mitigation strategies, as well as perform formulation studies in a laboratory setting as needed. Relationships: This position reports to the Associate Director, Drug Product Manu...