Associate Scientist II - Analytical Development

Novo Nordisk • Boulder, CO

7d • $110,000 - $125,000

About The Position

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 Novo Nordisk is seeking a highly motivated senior associate scientist to join the Analytical Development team in Boulder, CO. The candidate will be responsible for hands-on method development in the laboratory supporting analyses of phosphoramidites, oligonucleotides, intermediates and drug products. Experience in analytical method development, transfer, and validation in a cGMP environment with hands on experience using UHPLC’s, LC-MS for amidites, 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 Novo Nordisks’ GalXC and GalXC+ RNA platform products. Relationships This position reports to the Associate Director, Analytical Development as an individual contributor. Daily interaction with other peers in analytical development and/or process development teams in support of early phase product pipeline.

Requirements

• MS with 3+ years of industrial experience, or BS with 5+ years of industrial experience.
• Strong background in the analytical development of methods for the analysis of oligonucleotide therapeutics.
• Experience with IP-RP-UHPLC, MS and AX-HPLC analytical techniques using Agilent, Waters and/or Thermo UHPLC’s and associated software.
• 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.

Responsibilities

• Primary responsibility to provide analytical lab support for Novo Nordisks’ Oligonucleotide early phase pipeline.
• Development of robust IPRP, AX or mixed mode HPLC analytical methods for testing highly modified oligonucleotide drug substances, in-process samples, custom starting materials and drug products.
• Prepare analytical samples, analyze and process data, primarily by HPLC, LC-MS, KF, GC-FID/MS, etc.
• Lead efforts in LC-MS analysis for oligonucleotides and intermediates thereof in support of process development.
• Conduct and help design unique experiments to help in characterization of highly modified oligonucleotides.
• Conduct feasibility for finalized analytical methods in support of phase appropriate method qualifications as necessary.
• Operate, and troubleshoot lab instruments including but not limited to MS single quads, HPLC and UPLCs.
• Keep accurate records of the experiments utilizing GDP documentation and summarize the results in well communicated presentations or written reports.
• Contribute data for characterization and analytical sections of regulatory submissions
• Possess excellent written and verbal communication skills.
• Conduct laboratory work in an efficient manner that ensures a safe working environment

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees