AD, Cell Therapy Operations Manager - New York / Tri-State

Role Summary

This field-based, remote role supports key accounts in New York, Pennsylvania, and the Tri-State area. Travel and work hours will be defined by the hiring manager. As an Associate Director, Cell Therapy Operations Manager, you will develop, coordinate and support implementation of plans to train and qualify apheresis and treatment centers to treat patients with Novartis Oncology Cell Therapy products in commercial and clinical trial settings. You will manage CAR-T center operations, supporting qualified staff including HCPs, infusion nurses, study nurses, and apheresis unit and cell laboratory staff to ensure centers operate safely, efficiently and with ongoing operational improvements.

Responsibilities

• Partner and implement a One Team approach with commercial onboarding teams to support implementation of site onboarding as a supplier and end-user of commercial manufactured product. Support the efficient and effective qualification of key treatment and apheresis sites across North America to be in full compliance with Novartis policies and procedures
• 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
• Responsible for ensuring 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. Ensure that sites comply with Novartis onboarding requirements and while ensuring continued oversite identifying and escalating needs for reassessment of sites in their ability to supply material in accordance with Novartis manufacturing specifications and requirements
• 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. Oversee 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
• Support US functions in ‘localizing’ the center qualification framework according to country laws, regulations, Novartis Standard Operating Procedures including support in discussions with the relevant Health Authorities if applicable.
• Support consistent rollout of initial trainings including the Novartis Leukapheresis Manual, for Apheresis/Cell Lab/Pharmacy/Infusion Center (or Clinical Trial Handling Manual) and Final Mock Shipment by coordinating with local team and Customer Service Center team members
• Support Apheresis Quality on negotiation and maintenance of the Quality Apheresis Agreement in collaboration with legal teams and Strategic Account Managers
• Coordinate and guide a One Team approach with internal and external partners in clinical trial support 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
• Ensure best practice sharing amongst Cell Therapy Operations and escalate impediments to onboarding in a timely manner to leadership

Qualifications

• Minimum of 7 years of experience in at least one of the following areas:
• Experience in CAR-T
• Interacting and supporting external partners (e.g., clinical site coordinator, external supplier relations, key account manager)
• Hospital stakeholder management role
• Working in a pharmaceutical or hospital environment (e.g., medical, clinical, manufacturing, hospital, cell processing, or apheresis)
• Demonstrated ability to engage on medical topics with confidence while balancing an operational and strategic mindset
• Demonstrated project management experience, with ability to manage several deliverables in parallel
• Direct experience/knowledge related to cell apheresis, blood or tissue collection, or cryopreservation operations preferred
• Candidate must reside within territory, or within a reasonable daily commuting distance of 60 miles from the territory border. Ability to travel 60-80% over a broad geography is required, with the ability to drive and/or fly within the territory. Must have a valid driver’s license.

Education

• Bachelor’s Degree required. Business, medical or science education preferred

Additional Requirements

• Travel required: approximately 60-80% of time across a broad geography; must reside within territory or within 60 miles of the territory border; valid driver’s license required