Senior Analytical Development Manager

About the Department

The Boulder Site is home to the specialized technical operations/CMC team for oligonucleotides and RNAi therapeutics. 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.  Together, we are driving change. Are you ready to make a difference.

The Position

The Senior Analytical Development Manager plans and oversees analytical method validation and characterization studies for late-stage oligonucleotide assets and authors/reviews relevant sections of regulatory submissions.

Relationships

This position reports to the Director, Analytical Development.

Essential Functions

• Responsible for the oversight of development, transfer, and validation of analytical methods for custom phosphoramidite raw materials, oligonucleotide drug substances, and drug products at contract manufacturing organizations (CMOs) ensuring compliance with applicable ICH guidelines
• Establish and justify raw material, drug substance, and drug substance specification limits in alignment with regulatory requirements and IND/IMPD filings
• Design analytical characterization and comparability studies, including e.g., LC-MS characterization, forced degradation studies, diastereomer analysis to support changes to manufacturing, container closure, etc. in late-stage oligonucleotide development
• Actively contribute to the establishment of drug substance and drug product control strategies, ensuring that appropriate analytical methods are in place to support these strategies
• Troubleshoot analytical methods at CMO’s to resolve issues effectively
• Author and/or review relevant IND/IMPD and NDA/MAA Module 3 sections, ensuring accuracy and compliance with applicable regulatory standards
• Collaborate effectively with cross-functional teams, including analytical, manufacturing, chemical development, program management, and CMC regulatory

Physical Requirements

0-20% overnight travel required.

Qualifications

• Bachelor's degree from an accredited university and 7+ years of experience required. Equivalent experience requirements for advanced degrees would be a Master's degree and 5+ years of experience, or a PhD and 3+ years of experience
• Strong background in the analytical development and validation of methods for the analysis of oligonucleotide therapeutics
• Experience with IP-RP-UHPLC and AX-HPLC analytical techniques
• In depth knowledge of GLP/GMP’s in a pharmaceutical environment
• The successful candidate must possess excellent writing and communication skills and a demonstrated ability to work independently and with cross-functional teams

The base compensation range for this position is $120,300 to $222,600. 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 April 5th 2026. 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're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

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.