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Analytical Support Specialist : Analytical Development
Location:
Boulder, CO
Description:
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(TM) and GalXC:Plus(TM) 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 and 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 (IPCs) 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 UHPLCs, 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 stylemargin:bottom:11.0px::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 stylemargin:bottom:11.0px::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
Posted:
May 10 on Tip Top Job
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Analytical Support Specialist : Analytical Development is a Human Resource Support Worker Job located in Boulder CO. Find other listings like Analytical Support Specialist : Analytical Development by searching Oodle for Human Resource Support Worker Jobs.
Analytical Support Specialist : Analytical Development is a Human Resource Support Worker Job located in Boulder CO. Find other listings like Analytical Support Specialist : Analytical Development by searching Oodle for Human Resource Support Worker Jobs.