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Expert Science & Technology – Analytical Development


Database Development


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>Bench to bedside! This exciting role serves as a technical expert to develop, optimize, and implement novel analytical methodologies for our CAR-T cell therapy products. The successful candidate will work with a talented and experienced team in our Technical Research and Development organization at East Hanover, New Jersey. The candidate will be an important point of contact for the coordination and execution of molecular, potency and characterization assays, qualification studies, and method transfer activities within area of expertise. He/ She will interface regularly and build relationships with other functions such as Process Development, Quality Control and Manufacturing Sciences & Technology to collaboratively drive projects to meet the established timelines while maintaining the highest quality and data integrity standards. This individual will uphold Novartis Values & Beliefs and Code of Ethics to successfully support our bold mission of delivering effective CAR-T cell products for patients in need.<br><br>What you will be doing:<br><br>• Perform analytical testing including flow cytometry, cell count, cell viability, qPCR/dPCR, potency, etc. following appropriate SOPs and procedures<br>• Record and maintain meticulous records in electronic laboratory notebook in compliance with Quality standards<br>• Review and approve data by other team members<br>• Continuously identifies opportunities for method improvement. Implement resolution to technical challenges<br>• Execute qualification/optimization of analytical methods<br>• Drive project timelines and deliverables while meeting internal quality and data integrity requirements<br>• Communicate effectively and present complex data within the department and cross-functionally<br>• Author and review method related technical documents to ensure completeness, accuracy, consistency and clarity<br>• Support tracking and trending systems, and programs, which assist in the testing, evaluation and monitoring of quality and efficiency<br>[#video#{#400,300#}#/video#]