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 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

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 & operation 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.

Relationships

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.

Essential Functions

• 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

Physical Requirements

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.

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 degree in chemistry, biological sciences, or related field of study and 7+ years of QC lab experience required
• Minimum two or more (2+) years of leadership/management experience in a bio-tech /pharmaceutical chemistry laboratory preferred
• Knowledgeable in the following: Chemical analysis, GMPs, laboratory techniques: HPLC/ UPLC/ UV-VIS/ Karl Fischer/ TOC/ pH/ Conductivity/ Endotoxin/ GC-HS / FTIR
• Must demonstrate attention to detail, proofreading & strong computer skills with a willingness to learn new IT applications
• Demonstrated knowledge of US FDA, ICH Q7, & ISO regulations, guidelines, and applications of cGMP’s within Quality Control laboratory
• Demonstrated knowledge of pharmaceutical industry validation requirements as it relates to GMP Quality Control laboratory
• Excellent written & oral communication skills & the ability to author scientific & technical reports preferred
• Proven expertise in leading execution of a process, planning/organizing, checking results & creating the cycle plan in accordance with testing needs preferred

The base compensation range for this position is $150,000 to $175,000. 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.

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.