About the Department
Our Research & Development organization brings together the best minds in life science innovation. The teams located in facilities in Boulder, 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 Position
The Technical Team Lead, API Manufacturing works in Novo Nordisk's Boulder, Colorado Pilot Plants and is responsible for the production of oligonucleotide API to support toxicology studies or clinical trials. In addition to ensuring the supply of API and meeting production goals, the Technical Team Lead actively supports continuous improvement initiatives and identifies wherever possible improvements that reduce risk and cost to the overall operation.
Relationships
The Technical Team Lead, API Manufacturing reports to the Senior Manager, API Manufacturing. The Technical Team Lead works with Chemical Development, Analytical Manufacturing, Engineering, Facilities, EH&S, Program Management and Quality Assurance. The Technical Team Lead, API Manufacturing acts as a delegate for the Senior Manager API Manufacturing.
Essential Functions
Responsible for the manufacture of oligonucleotide API ensuring compliance to cGXP, safety, regulatory, and business processes and/or procedures
Commission, qualify, operate, maintain, and troubleshoot pilot plant equipment such as oligonucleotide synthesizers, purification systems, lyophilizers, and analytical instrumentation
In collaboration with Chemical Development and Manufacturing, transfer and scale-up processes from laboratory to pilot plant scale
Author and/or review batch documentation (batch records, data capture forms, solution preparation forms, SOPs, work instructions, etc.) and generate automated equipment methods
Execute manufacturing schedule to achieve manufacturing goals
Safely handle hazardous materials/waste including organic solvents, strong acids and bases
Lead troubleshooting efforts for process and equipment issues; develop and implement corrective actions
Investigate unexpected or aberrant results during production to provide suitable root cause investigation analysis
Support the technology transfer of manufacturing processes between Manufacturing Facilities
Responsible for routine communication to all levels of the organization on manufacturing activity
Support equipment calibration and maintenance programs
Provides training, technical mentorship, scientific guidance, and peer leadership to junior staff
Physical Requirements
0-10% overnight travel required. Ability to sit, stand, reach, bend, climb, balance, walk, and finger. 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.
Qualifications
Bachelor's degree in Life Science, Chemistry, or Engineering with at least eight (8) years of relevant experience; a Master's Degree in Life Science, Chemistry, or Engineering with at least six (6) years of relevant experience; or twelve (12) years of relevant experience with a High School diploma is required
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 multi-tasking skills, attention to detail, and the ability to adapt to changing priorities
Basic computer literacy including, but not limited the use of MS Office suite programs (Word, Excel, Outlook)
Familiarity with the transfer and scale-up of development processes to the manufacturing scale is preferred
Experience with new plant startup and operation is desired
The base compensation range for this position is $120,000 to $150,000. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance.
Novo Nordisk offers long-term incentive compensation and or company vehicles depending on the position's level or other company factors.
Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time policy, flex-able vacation policy, and parental leave policy.
The job posting is anticipated to close on March 15th, 2025. The Company may however extend this time-period, in which case the posting will remain available on our careers website at www.novonordisk-us/careers.com.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we're life changing.
Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.
If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
