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Associate Director, Cell Therapy Operations Manager-Northwest (Remote) (347916BR)





Seattle, Washington, United States

Job Description Over 108,000. That’s how many US patients our oncology products touched in 2018. And while we’re proud of that, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives? We believe the answers are found when curious, courageous and collaborative people like you are empowered to ask new questions, make bolder decisions and take smarter risks

At Novartis, we are reimagining medicine to address some of society’s most challenging healthcare issues. We discover and develop breakthrough treatments and find new ways to deliver them to as many people as possible.

As an Associate Director, Cell Therapy Operations Manager, you will develop, coordinate and support implementation of the plan to train and qualify apheresis and treatment centers to be able to treat patients with the Novartis Oncology Cell Therapy products both in commercial and clinical trial setting. In this role, you will manage CAR-T center operations supporting qualified key staff including HCPs, infusion nurses, study nurses as well as apheresis unit and cell laboratory staff, ensuring that the centers are operating to safely and efficiently treat patients with our products and supporting continuous operations improvements.

Your responsibilities include, but are not limited to:
• Support the efficient and effective qualification of key treatment and apheresis centers across your territory of North America by coordinating with strategic account managers, medical, market access, local QA, Apheresis QA and Customer Service Center in full compliance with FDA and local laws and regulations
• Ensure high quality consistent supply of human cells and tissues (HCT) intended for use as manufacturing starting material in GMP manufacturing of cell therapy products through assessment, selection, approval, initiation, and monitoring of hospitals/apheresis centers that will collect and process HCT
• Support consistent rollout of initial trainings including Leukapheresis manual, product ordering management and cancellation/product replacement/credit request, patient consent, Risk Management Plan procedures for Cell Lab/Pharmacy/Infusion Center (or Clinical Trial Handling Manual) and Mock Shipment by coordinating with local team and Customer Service Center team
• Deliver onsite support for 1st order process management including apheresis cell collection(s), cell processing and shipment of starting material as well as the reception through the administration of the final product according to Novartis specifications and processes as well as local laws and regulations
• Develop and support implementation of new operational service offerings to improve the customer experience (e.g., educational programs, process solutions)
• Conduct investigations in case of deviations on starting material and oversight of the end-to-end process deviations in close coordination with all relevant functions.

This position can be based remotely in Northern California, Washington, Oregon, Idaho or Wyoming. Residence in other states will be considered if near an airport. (There may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. This position will require up to 60% travel.