Specialist- API Manufacturing

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.

The Specialist, API Manufacturing works in Novo Nordisk's Boulder, Colorado manufacturing facilities and is responsible for the production oligonucleotide API to support toxicology studies or clinical trials. In addition to ensuring the supply of API and meeting production goals, the Specialist actively supports continuous improvement initiatives and identifies wherever possible improvements that reduce risk and cost to the overall operation.

Specialist, API Manufacturing reports to the Senior Manager, API Manufacturing. The Specialist, API Manufacturing works with Chemical Development, Analytical Services, Engineering, Facilities, EH&S, Program Management and Quality Assurance.

• Responsible for the manufacture of oligonucleotide API ensuring compliance to cGXP, safety, regulatory, and business processes and/or procedures
• Commission, operate, maintain, and troubleshoot pilot plant equipment such as oligonucleotide synthesizers, purification systems, lyophilizers, and analytical instrumentation
• In collaboration with Chemical Development, transfer and scale‑up processes from laboratory to manufacturing scale
• Author and/or review batch documentation, operational procedures, forms, and other required documents. Generate automated equipment methods
• Maintains a clean, safe, and well‑organized work environment
• Execute manufacturing schedule to achieve manufacturing goals
• Safely handle hazardous materials/waste including organic solvents, strong acids and bases
• Identify and troubleshoot technical issues with the process and equipment
• Investigate unexpected or aberrant results during production to provide suitable root cause investigation analysis
• Responsible for routine communication to all levels of the organization on manufacturing activity
• Provides cross‑functional site support as needed, including facility maintenance, equipment maintenance and calibration, and inventory control.
• Support equipment calibration and maintenance programs
• Provides training to other staff members
• Perform other tasks as necessary or assigned

Ability to sit, stand, reach, bend, climb, balance, walk, and use hands/fingers. Ability to lift up to 50lbs of force occasionally, and/or up to 30 pounds of force frequently, and/or up to 10 pounds of force constantly to move objects. Visual acuity to determine accuracy, neatness, and thoroughness of work and to make general observations.

• Bachelor’s degree in Life Science, Chemistry, or Engineering with at least four (4) years of relevant experience or eight (8) years of relevant experience with a High School diploma
• Strong background in oligonucleotide‑based drug substance development and manufacturing including knowledge of nucleic acid synthesis, purification, ultrafiltration, annealing and lyophilization techniques and equipment is highly desired
• Requires a proficient understanding of cGXP and applicable regulations and guidelines
• Working knowledge of control software for automated oligonucleotide synthesizers and/or chromatography systems is highly desired
• Mechanical aptitude with ability to use tools to perform tasks, basic troubleshooting of mechanical components and systems
• Ability to work independently and within teams that consist of members with different degrees of knowledge or ability
• Possess excellent written and verbal communication skills
• Excellent organizational and…