Lead 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 Position

The Technical Team Lead API Manufacturing works in Novo Nordisks Boulder Clinical Pilot Plant and is responsible for the production of GMP oligonucleotide API to support toxicology 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 Services 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 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 pilot plant scale
• Author and/or review batch documentation (data capture forms solution preparation forms 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 into Phase I/II cGMP 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

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

• Bachelors degree in Life Science Chemistry or Engineering with at least eight (8) years of relevant experience; a Masters 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

Novo Nordisk is currently in the process of adjusting job titles globally. Please note that the job title listed in this advertisement may be subject to change. More detailed information will be provided during the recruitment process.

The base compensation range for this position is $96670 to $178840. 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 positions 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.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

Were not your typical healthcare a modern world of quick fixes we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science make healthcare more accessible and treat prevent and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real lasting change in health.

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-. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.