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Expert Science & Technology (Stability Management)


Information Technology


Durham, North Carolina, United States

12,000. The number of associates worldwide working together to reimagine medicine! <br><br>The Global Drug Development (GDD) organization oversees the development of new medicines discovered by our researchers and partners. We transform the lives of people by developing innovative and life-changing medicines.<br><br>The Expert Science & Technology role will manage the planning/strategy, study designs, data and analysis, report generation and regulatory submissions for development stability programs within the Technical Research & Development, Cell & Gene Therapy Organization.<br><br>Your responsibilities will include, but are not limited to:<br><br>• Responsible for establishing stability strategies and designing protocols. <br>• Own and generate technical reports, records, and regulatory submission source documents. <br>• Data management to support the Stability Programs including the administration of stability samples, associated document coordination, and collection and evaluation of data.<br>• Management of external service providers performing execution and testing of stability studies.<br>• Ensures scheduling of stability lots, tracks stability time points and evaluates stability data on a routine basis. <br>• Document owner for procedures and work instructions in support of stability processes.<br>• Owner, assessor and/or reviewer of stability related out of trend (OOT), out of specification (OOS) events, deviations and change controls. <br>• Support of Sample Management duties and other related job duties as assigned.<br><br><br>[#video#{#400,300#}#/video#]