Senior Manager, Quality Control

About the Department

Our Research & Development organization brings together the best minds in life science innovation. The teams located in facilities in Lexington, Watertown, Cambridge and Seattle reflect the full R&D continuum, from early research through late-stage clinical development. Here, we are building for the future, creating a distinct R&D community based on collaboration, partnerships, and cutting‑edge research across multiple modalities and therapeutic areas.

We recognize that improving human health starts here and that patients rely on us. Our R&D hub merges biotech speed and agility with large pharmaceutical company quality, resources, and stability, uniting the best of both worlds to develop new medicines for patients.

Novo Nordisk is seeking a Quality Control Manager to support the successful start‑up of the Quality Control laboratory supporting phase 1 and 2 oligonucleotide drug substance manufacturing. The QC Manager position will manage all activities related to the establishment & operating of the Quality Control Chemistry laboratory supporting analysis of raw materials, in‑process, final product samples, as well as routine stability samples for Novo Nordisk's phase 1 and 2 oligonucleotide API pilot facility located in Boulder Colorado.

This role is a people manager and may manage up to 5 QC analysts, locally. This position requires a candidate with a robust background in analytical chemistry or a related field, coupled with significant experience in GMP laboratory settings and leadership roles. The ideal candidate will demonstrate proficiency in various laboratory techniques, regulatory knowledge, and strong communication skills, ensuring efficient and compliant laboratory operations.

This position reports to the Associate Director, Quality Control. Daily interactions with peers in manufacturing in support of Phase 1 and 2 drug substance production. Routine interactions with analytical development for implementation and validation of analytical methods.

• Requires full‑time, on‑site presence in support of manufacturing operations
• Oversee the establishment of a GMP QC Laboratory including equipment qualification and resource planning specific to the analytical QC laboratory
• Assist with implementation and integration LIMS and other Novo software systems as they relate to Quality Control
• Create and refine process and procedures for QC related testing such as, but not limited to:
  Appearance, HPLC, UPLC and GC analysis, Karl Fischer, UV, pH, Conductivity, TOC, endotoxin, and FTIR
• Work closely with Analytical Development on method validation protocols and execution relevant to product methods
• Routine analysis of raw materials, in‑process, release, and stability samples to support phase 1 and 2 drug substance manufacturing
• Collaborate with Analytical Development to resolve method and instrument performance issues as needed
• Coordinate with the Associate Director of QC and other teams to address workload issues and prioritize tasks effectively
• Ensure effective communication and knowledge transfer with internal customers, aligning with all relevant stakeholders
• Support the training and development of personnel
• Other responsibilities, as assigned

0-10% overnight travel required. Occasionally moves equipment and/or supplies weighing up to 50 pounds within the facility using various body positions. Ability to do close precision work with their hands. Must be ability to remain in a stationary position 50% of the time. Occasionally works around odorous and/or hazardous materials. Ability to work in an operating laboratory and open office environment with the possibility of frequent distraction.

Supervisory. Ensure that reporting personnel have individual development plans (IDP), with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process. Ensure that the IDP forms include completed learning and aspiration…