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Job Juncture: Sr. Manager, Oligonucleotide Analytical Development

Job Juncture

This is a Full-time position in Boulder, CO posted September 15, 2020.


Manager, Oligonucleotide Analytical DevelopmentMy client is expanding and seeks a Sr Manager to oversee analytical development for oligonucleotide development.

The ideal candidate will take on the following tasks:Direct daily activities of CROs and oversee the characterization efforts, method optimization, validation, and transfer activities, and stability study management for APIs and drug productsManage the characterization of product and impurities and determine degradation pathways.Collaborate with QC, manufacturing, QA, and regulatory counterparts to develop protocols and reports for API and DP, including trending analysis, etc.Prepare and review of relevant CMC sections in support of regulatory submissions.Oversee stability programs, including review of stability protocols, reports and data, data management and trendingSupport batch record review and QC data, including trending The ideal candidate will possess the following qualities:Scientific degree and extensive analytical experience, including working with oligonucleotidesExperience with Mass Spectroscopy desiredPrevious management of CROsExperience setting specifications based upon statistical analysis and reviewing deviations, OOS, OOT, and change controlsExcellent technical writing skills and editing of technical reports, including CMC regulatory filingsThorough knowledge of GMPs, ICH, USP, EP