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
We are seeking a highly motivated, organized, and detail-oriented individual with experience in clinical and commercial logistics. Responsible for global shipping and storage of critical starting materials, drug substance, and drug product and to assist with other supply chain activities. Must have experience with international shipping of pharmaceutical materials and customs requirements.
Relationships
This position will report to the Director of Supply Chain.
Essential Functions
Primary point of contact for all activities regarding Logistics and Global Trade Compliance Well versed in requirements for international shipments associated with GMP and laboratory samples Initiate, monitor, and complete shipments associated with raw materials, drug substance, drug product, and finished goods Authoring and implementing Veeva policies and SOPs for process establishment and efficiencies Manage TIB reconciliation strategy to ensure compliance with US Customs and Border Patrol Ensure prompt shipment related communication to key internal stakeholders Provide trainings and Lunch-and-Learns for internal stakeholders Improve tracking system for shipments Leverage Novo Nordisk HQ processes and contracts where appropriate to improve the shipping process Management of outsourced inventory (Raw materials, Drug substance, Drug Product) Lead continuous improvement activities at outsourced CMOs Review and execution to discard expired material as needed at warehouses to ensure inventory optimization Drive the internal and external investigation of errors or non-conformances, and preparing corrective and preventative action plans (CAPAs) in conjunction with QA and impacted departments Import/export expertise – ensure trade compliance with regards to imports and exports: Filings with World Customs Brokerage and US Customs and Border Protection HTS classification and material valuations to ensure material is identified appropriately Incoterms to ensure shipment terms are appropriate Review and analysis of temperature controlled shipments to maintain temperature requirements in transit 3PL management Review of Amidite retest dates and process for obtaining new CoAs from suppliers as needed Shipping and logistics budget analysis and preparation Responsibility for PO generation and invoice review and approval for all shipments and storage fees Ad-hoc shipping and logistics cost analysis projects
Physical Requirements
0-10% overnight travel required. Travel 10%. Travel to other Novo Nordisk locations, storage facilities, CMO’s may be required up to 10% of the time.
The incumbent may work remotely from any location within the United States, as approved.
Qualifications
BS with 8+ years or MS with 6+ years of relevant supply chain or logistics experience required. Degree in business or related subject matter required. Equvalent supply chain or logistics experience may be subsituted for a degree, when apppropriate Detailed knowledge of import/export requirements for GMP and raw materials Excellent knowledge of logistics procedures Experience in Biopharmaceutical & clinical planning Experience in materials management CPIM/CLTD/CSCP certification a plus Strong interpersonal skills and business acumen, excellence in building and managing relationships, ability to understand all perspectives, find common ground and effectively bridge significant differences Ability to collaborate professionally, effectively, and efficiently with internal and external teams Demonstrated ability to work independently and with cross-functional teams, including Supply Chain, CMC, Quality, Finance
The base compensation range for this position is $150,000 to $167,000. 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 February 22, 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.