Senior Manager - Manufacturing & Development
Novo Nordisk
- Boulder, CO
- $150,000-175,000 per year
- Permanent
- Full-time
Accept ClosePress Tab to Move to Skip to Content LinkSearch by KeywordSearch by LocationLoading...Category×Select how often (in days) to receive an alert:×Select how often (in days) to receive an alert:Senior Manager - Manufacturing & DevelopmentFacility: ManufacturingLocation:Boulder, CO, USAbout the DepartmentThe Boulder Site is home to the specialized technical operations/CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the hub for all manufacturing-related activities for GalXC™ and GalXC-Plus™ investigational therapeutics developed from Novo Nordisk's acquisition of Dicerna Pharmaceuticals, Inc. in December 2021. With a new laboratory completed in 2021 to support analytical and process development, 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. Ranked the No. 1 Place to Live for the second consecutive year by U.S. News & World Report, Boulder is experiencing a renaissance in biotech investment and is one of the world's leading centers for oligonucleotide innovation and manufacturing. Together, we are driving change. Are you ready to make a difference?The PositionThe Senior Manager of Specialty Raw Materials Manufacturing is responsible for ensuring a steady supply of phosphoramidites and other critical raw materials for RNAi CMC Boulder.In addition to ensuring the supply of raw materials, during the execution of his/her duties, the Manager/Senior Manager should seek to actively improve existing manufacturing processes, identifying, and wherever possible, reducing risk and cost to the overall operation.The Senior Manager may be called upon to facilitate the search for new or improved versions of raw materials, partnering with Chemical Development and external suppliers to ensure a smooth and timely delivery.RelationshipsAssociate Director of Amidite Manufacturing.Owner of business relationships with Raw Material (RM) suppliers and should work within Supply Chain and CMC to meet phosphoramidite demand.This role is for an individual contributor.Essential Functions
- Manage manufacturing of phosphoramidites at suppliers for multiple programs. Review manufacturing updates and reports from vendors.
- Independently evaluate, plan and execute strategic process development projects for sustainable manufacture of key custom phosphoramidites and raw materials at vendors.
- Write RFPs and review quotations.
- Strategize and initiate cost saving and sourcing intelligence for phosphoramidites and deliver maximum value to programs.
- Collaborate with Materials Management to meet forecasted raw material needs without impacting program timelines.
- Act as point of accountability for delivery of phosphoramidites to support a cross functional program teams.
- Education Level:
- PhD with 3+ years relevant experience within field of expertise, Masters with 5+ years relevant experience within field of expertise, Bachelor with 8+ years relevant experience within field of expertise or equivalent knowledge through relevant practical experience
- Chemistry or Chemical Engineering Degree is required
- Experience Level:
- Experience managing external relationships with or at CMOs/CROs is required
- Working knowledge of regulations associated with GxP/cGMP manufacturing is require
- Strong project management skills are required
- Experience with nucleic acid chemistry and/or peptide manufacture is a preferred
- Experience with CMOs/CROs is preferred