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Job Details


Senior Expert - Science & Technology – Drug Product (336975BR)





Durham, North Carolina, United States

Job Description 12,000. The number of associates worldwide working together to reimagine medicine!

What you'll be doing:
• Advances complex drug product process development efforts as a technical lead within a cross-functional team across Novartis sites and organizations.
• Leads projects within the drug product unit to enhance manufacturing gene therapy technologies, capabilities, and processes.
• 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.
• Provide scientific and technical input for Drug Product/Fill-Finish process-related issues at internal Novartis sites, as well as with external partners.
• Identify and implement potential process improvements in conjunction with manufacturing operations.
• 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).
• Support tech transfer and participate in start-up efforts of new products, equipment, software or processes in manufacturing.
• Support regulatory applications as subject matter expert for Drug Product/Fill-Finish operations and process development experiments.