AD, Cell Therapy Operations Manager - Pacific Northwest

Job Description Summary

The Associate Director, Cell Therapy Operations Manager - Pacific Northwest develops, coordinates and supports implementation of the plan to train/qualify apheresis and treatment centers to be able to treat patients with Novartis Cell Therapy products both in commercial and clinical trial settings. In this role, you will manage CAR-T center operations supporting qualified key staff including HCPs and 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.

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Job Description

Key Responsibilities:

• Build strong relationships with internal and external territory key stakeholders to provide best in class customer support. Partner and execute a One Team approach with commercial onboarding teams, including Strategic Account Managers, Kymriah CARES and Apheresis Quality to support implementation of site onboarding as a supplier and end-user of commercial manufactured product.

• Coordinate and guide a One Team approach adhering to GCP with internal and external stakeholders in clinical trial support & site onboarding across teams to include Novartis Medical, Novartis Trial Management, Clinical Customer Support, Apheresis Quality and assigned site Clinical Research Associates to ensure successful clinical trial site participation.
• Provide highly engaged site operations support to approved external site staff with a focus on providing guidance as well as continued training based upon approved Novartis messaging through customer facing with ordering physicians, clinical trial Primary Investigators, BMT coordinators, pharmacy, Infusion Nursing Teams, Clinical Trial Coordinators, as well as apheresis units and cell laboratory staff.
• Ensure that sites provide a high-quality consistent supply of starting material for the GMP manufacturing of Cell Therapy products through assessment, approval, initiation, and monitoring of incoming material batches from assigned territory sites.
• Conduct investigations in partnership with Apheresis Quality within the Novartis quality platform through assigned deviations related to incoming specifications, chain of identity breaches, and other related deviations of Novartis manufacturing specification as well as investigating manufacturing results when requested. Oversight of the end-to-end process of deviations in close coordination with all relevant functions to ensure closure of deviation within the due date assigned to each deviation.
• Deliver onsite support for first order, or any time after due to site inactivity; recent site deviations, or due to significant changes in Novartis processes requiring site refresher training. Onsite activities for first collection or any time after will be dependent upon assessments and can be related to cell collection, cell processing and/or shipment of starting material as well as the receipt of final product through the administration of the final product according to Novartis specifications and processes as well as local laws and regulations
• Ensure best practice sharing amongst Cell Therapy Operations and escalate impediments to onboarding in a timely manner to leadership.
• Conduct Periodic Quality Reviews of sites in accordance with Novartis Standard Operating Procedures and meet all timelines associated (PQRs). Manage follow-up of internal and external activities in collaboration within the Novartis One Team approach.
• Complete internal training as a Certified Novartis Investigator and function fully within the Novartis quality tracking program, in partnership with the Apheresis Quality team to ensure all investigations and/or quality events to site activities are completed/evaluated while providing follow-up including, but not limited, to onsite refresher training to the sites supplying the cell material as appropriate.
• Partner with internal stakeholders in relation to management of final product deviations/issues and implement trainings plans

The AD, Cell Therapy Operations Manager requires up to 60-70% travel to cover the Pacific Northwest territory of Oregon, California, Nevada, Montana, and Washington state. This role can be based remotely anywhere in the U.S., if the employee is based near a major 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) is defined by the hiring manager.

Essential Requirements: