Associate Scientist II - Analytical Development
Novo Nordisk
- Boulder, CO
- $80,000-120,000 per year
- Permanent
- Full-time
Accept ClosePress Tab to Move to Skip to Content LinkSearch by KeywordSearch by LocationLoading...Category×Select how often (in days) to receive an alert:×Select how often (in days) to receive an alert:Associate Scientist II - Analytical DevelopmentFacility: ManufacturingLocation:Boulder, CO, USAbout the DepartmentThe 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 PositionNovo Nordisk is seeking a highly motivated associate scientist to join the Analytical Development team in Boulder, CO. The candidate will be responsible for method development in the laboratory for support in 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 Dicerna and Novo Nordisks' GalXC and GalXC+ platform products.RelationshipsThis position reports to the Manager, 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.Essential Functions
- 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.
- Conduct and help design unique experiments to help in characterization of highly modified oligonucleotides
- Conduct Phase appropriate method qualifications as necessary
- Operate, and troubleshoot lab instruments
- 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
- 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 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