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Associate Director, Head of Drug Product – Product Leaders

Management

Executive Director

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>•Leads and manages all project/network activities and apply scientific/technical expertise to address complex R&D issues and actively support TRD strategies and goals by participating in cross-functional teams. <br>• Leads scientific programs; coordinates interdisciplinary projects and teams. <br>• Develops long term strategies and applies and/or develops highly advanced technologies, scientific principles, theories and concepts.<br>• Acts as team leader of the assigned team <br>• Influences, leads and manages all project/network/platform activities and applies scientific/technical expertise<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.[#video#https://youtu.be/ggbnzRY9z8w{#400,300#}#/video#]