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
This position is an experienced professional with the ability to support process establishment and manufacturing activities for Novo Nordisk's oligonucleotide investigational product pipeline. This individual will be responsible for drug substance manufacturing and development at Commercial Manufacturing Organizations (CMO's) and Novo Nordisk internal manufacturing sites.
Relationships
This position reports to the Associate Director of Drug Substance Development and Manufacturing. This position interacts with QA, QC, Internal Chemical Development, Drug Product Manufacturing, Program Management, CMC Regulatory, Manufacturing Operations, and Contract Manufacturing Organizations. This role is based in Boulder, CO.
Essential Functions
Support establishment and optimization activities developing scalable processes for oligonucleotides. Ensure process strategies developed at laboratory scale can achieve control limits and specifications intended for large scale manufacturing
Serve as primary management & technical lead, overseeing CMO activities. Provide guidance for the process development life cycle and how early phase development transitions into commercial manufacturing
Support the authoring and review of technical reports and protocols in support of cGMP activities. Serve as the technical expert supporting the development of process characterization protocols. Ensure documents are scientifically sound and conducted within timelines
Support the technology transfer and scale up of internally & externally developed platform technologies to partner CMO's or internal manufacturing
Collaborate with cross functional teams for external or internal cGMP manufacturing of drug substance API. Communicate Novo Nordisk manufacturing decisions to CMO's in a clear, concise, and timely manner
Support the review and approval of cGMP batch documentation that ensures manufacturing can achieve the intended process control strategies. Review and approve change controls, in-process control sampling plans, and CAPA's
Perform risk evaluations of manufacturing processes and develop appropriate mitigation plans
Coordinate with QA, regulatory, and analytical development to determine documentation for RNAi programs through all phases of product/process development and manufacturing
Exercise sound judgement within broadly defined practices and policies in selecting techniques and evaluation criteria for obtaining results
Physical Requirements
Travel required ~4x per year, 2x per year international (Possible). Most travel will be overnight.
Qualifications
Bachelor's degree with 7+ years or Master's degree with 5+ years of relevant experience in the pharmaceutical, biotechnology or related industry, focused on drug substance development or manufacturing required. Degree in life sciences or a related field required
Strong background in oligonucleotide-based drug substance manufacturing process development is highly desired
Knowledge of nucleic acids synthesis, purification, annealing techniques and/or analytical development of oligonucleotide analysis methods is highly desired
Experience with AKTA 100 and AKTA purification systems is highly desired
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 $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.
