Analytical Support Specialist - Analytical Development

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

Novo Nordisk is seeking a highly motivated analytical support specialist to join the Analytical Development team in Boulder, CO. The candidate will be responsible for various analytical laboratory activities including but not limited to: method development and transfer of methods for oligonucleotide intermediates (IPC's) as well as drug substance and drug product release within a nonGMP lab. The pprimary funtion of the position will be in support of nonGMP manufacturing of oligonucleotides and associate raw materials if applicable. Experience in quality control, analytical method, transfer, and qualification in a GDP/GLP environment with hands on experience using UHPLC's, KF, GC-MS, UV-vis and LC-MS for oligonucleotides and intermediates is desired. This position will support therapeutic programs in multiple disease areas and be a key contributor in supporting the technical operations team for Dicerna and Novo Nordisks' GalXC and GalXC+ platform products.

Relationships

This position reports to the Manager, Analytical Development as an individual contributor. Daily interaction with other peers in analytical development, process development and manufacturing teams in support of early phase product pipeline.

Essential Functions

• Provide analytical support for nonGMP manufacturing of Oligonucleotides (drug substance)
• Conduct analytical method feasibility and transfers from the analytical development team into the on-site analytical lab for nonGMP manufacturing
• Draft work instructions for use in nonGMP analysis
• Conduct in-process and final batch analyses for manufacturing of oligonucleotides
• Provide analytical support for drug product formulation studies, including osmolality, viscosity, HPLC, UV
• Conduct stability studies for drug substance and drug product
• Ability to run a multitude of analytical instrumentation to support manufacturing; UV-vis, KF, HPLC, GC, LC-MS, Endotoxin, etc.
• Knowledge of calibration and routine maintenance of instrumentation used in the analytical lab
• Ability to prepare and analyze samples accurately
• Keep accurate records in accordance with GDP, process data and provide detailed results for manufacturing
• Conduct laboratory work in safe, efficient manner
• Ability to complete sample analyses in an efficient, time sensitive nature in support of production timelines
• Possess excellent written and verbal communication skills
• Ability to work in a very dynamic environment, both independent projects as well as in support of cross functional teams

Physical Requirements

0-5% overnight travel required.

Qualifications

• MS with 2+ years of industrial experience, or BS with 4+ years of industrial experience
• Strong background in the analysis of drug substance and drug products for oligonucleotide therapeutics
• Experience with UV-vis, KF, GC-MS-FID, LC-MS, IPRP-UHPLC and AX-HPLC analytical techniques using Agilent, Waters and/or Thermo UHPLC’s and associated software is preferred
• In depth knowledge of GLP/GDP/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 $80,000 to $120,000. 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 06/09/2024. 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.