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Job Details

Bioanalytical Assay Scientist

Science and Research



East Hanover, New Jersey, 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>Under general direction, the Expert (Scientist) Science & Technology will perform bioanalytical testing and other activities and functions to ensure timely testing and release of products, collaborate with the team in the design and execution of validation and other projects. Support additional projects as required. Monitor processes and products to identify opportunities for continuous improvement.<br><br>***Shift Position: Sunday - Wednesday, 12pm - 10pm***<br><br>Your responsibilities will include, but are not limited to:<br>• Perform Bioanalytical testing including flow cytometry, cell count, cell viability, qPCR, etc. in support of clinical release strategies in addition to non-standard studies/projects<br>• Performs inspections and testing of raw materials.<br>• Document results within electronic and paper-based systems accordingly.<br>• Support review of analytical data and archiving in lab documentation systems. <br>• Support and/or handle tracking and trending systems, and programs that assist in the testing, evaluation and monitoring of quality, assay performance and efficiency. May be required to train other associates in specific areas of competency. <br>• Ensure assigned analytical methods are ready to be performed when required including management of reagent and equipment inventory <br>• Support external teams in qualifying new and/or replacement equipment within the laboratory<br>• Support execution of method qualification/development & optimization/transfer as governed by protocols and/or under the supervision of senior lab staff.<br>• Draft under supervision basic protocols in support of laboratory execution requirements as per ICH and NVS guidelines<br>• Contribute to writing of OOS/OOE/OOT and deviation investigations as well as designing CAPA outcomes<br>• Support Change control and revise SOPs, forms, laboratory test records as required using appropriate electronic systems.<br>• Support laboratory management in drafting analytical response/strategy documents.<br>• Support internal and external audits of facility.<br>• Ensures all assigned training is completed within required time frame<br><br>[#video#{#400,300#}#/video#]