About the Department
The 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 Position
This position is a leadership position that supports Novo Nordisk's GALXC and GALXC+ investigational products pipeline by managing internal manufacturing of API for RNAi CMC Boulder. In addition to ensuring the supply of API, during the execution of the job duties, the senior manager should seek to actively support continuous improvement initiatives and identify wherever possible improvements that will reduce risk and cost to the overall operation.
Relationships
This position reports to the Director of API Manufacturing.
This position interacts with Chemical Development, AD/QC, Engineering, Facilities, Program Management and QA.
Essential Functions
Accountable for the management and development of internal manufacturing resources Responsible for API manufacturing activities assuring the manufacturing resources comply to all safety, GXP, regulatory and business processes or procedures Ensure the operating efficiency of the department and support continuous improvement objectives Responsible for delivering key performance objectives for the department to meet program deadlines and time schedules Serve as internal Manufacturing Operations representative for oligonucleotide development programs manufactured in the Boulder Pilot Plant Manage in collaboration with Chemical Development and Manufacturing, the transfer and scale up of processes to the manufacturing scale and Pilot Plant equipment Support the technology transfer of internal manufacturing processes to the partner CMO's Support the investigation of unexpected or aberrant results during internal manufacturing operations to suitable root cause investigation analysis Responsible for routine communication to all levels of the organization on Pilot Plant activity Work with internal and external resources to develop and review manufacturing documentation, SOPs, protocols, risk assessments and reports Support equipment calibration and maintenance programs
Physical Requirements
0-10% overnight travel required. Lifting up to 50lbs/23kg of force occasionally, and/or up to 30 pounds of force frequently, and/or up to 10 pounds of force constantly to move objects.
Development of People
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 plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility.
Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way.
Qualifications
Bachelor's or more advanced degree in Life Science or related field Minimum of eight (8) years of relevant experience in the pharmaceutical, biotechnology or related industry focused on drug development and manufacturing 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 Experience in the transfer and scale-up of development processes to the manufacturing scale Experience with new plant startup and operations is preferred Possess excellent written and verbal communication skills Thorough understanding of cGXP and applicable regulations, ability to interpret and apply regulations to complex issues to make risk management recommendations Ability to manage people and competing priorities and timelines in a fast-paced, rapid-growth environment
The base compensation range for this position is $150,000 to $ 190,000. 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. The job posting is anticipated to close on 01/21/2025. 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.
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.
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.