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Senior Expert - Science & Technology – Drug Product

Technology

Product Manager

No

Durham, North Carolina, United States

12,000. The number of associates worldwide working together to reimagine medicine! <br><br>What you'll be doing:<br>• Advances complex drug product process development efforts as a technical lead within a cross-functional team across Novartis sites and organizations.<br>• Leads projects within the drug product unit to enhance manufacturing gene therapy technologies, capabilities, and processes. <br>• Independently plans, designs, executes and interprets complex development studies (with multiple experiment sets) related to process development and scale-up, ensuring studies balance time and resources. Drives results and generates innovative solutions; takes independent action to solve scientific problems and drive their resolution.<br>• Provide scientific and technical input for Drug Product/Fill-Finish process-related issues at internal Novartis sites, as well as with external partners.<br>• Identify and implement potential process improvements in conjunction with manufacturing operations.<br>• Provide technical/scientific support in process development and qualification efforts in pre-clinical and clinical manufacturing through laboratory studies designed to illuminate fundamental process and product performance (e.g. NOR & PAR setting, CPP edge of failure, CQA performance).<br>• Support tech transfer and participate in start-up efforts of new products, equipment, software or processes in manufacturing.<br>• Support regulatory applications as subject matter expert for Drug Product/Fill-Finish operations and process development experiments.<br><br>[#video#https://youtu.be/ggbnzRY9z8w{#400,300#}#/video#]