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

Role Summary

Field-based and remote opportunity supporting key accounts in New York and Pennsylvania. Responsible for training and qualifying apheresis and treatment centers to treat patients with Novartis Oncology Cell Therapy products in commercial and clinical trial settings. Manages CAR-T center operations, supporting qualified staff including health care professionals, infusion nurses, study nurses, and apheresis unit and cell laboratory staff to ensure centers operate safely and efficiently with ongoing improvements. Travel and working hours will be defined by the hiring manager.

Responsibilities

• Partner and implement a One Team approach with commercial onboarding teams to support site onboarding as a supplier and end-user of commercial manufactured product; support efficient 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 guidance and training based upon approved Novartis messaging through interactions with ordering physicians, clinical trial Principal 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 GMP manufacturing of Cell Therapy products through assessment, approval, initiation, and monitoring of incoming material batches from assigned territory sites; ensure onboarding requirements and ongoing oversight
• Conduct investigations in partnership with Apheresis Quality within the Novartis quality platform related to deviations in incoming specifications, chain of identity breaches, and other deviations of manufacturing specification; oversee end-to-end deviation processes to closure by due date
• Deliver onsite support for first order or after due to site inactivity; recent site deviations, or significant changes in Novartis processes requiring site refresher training; onsite activities may involve cell collection, cell processing, shipment of starting material, and receipt of final product according to Novartis specifications and local regulations
• Support US functions in localizing the center qualification framework according to country laws, regulations, and Novartis SOPs, including discussions with relevant Health Authorities if applicable
• Support rollout of initial trainings including the 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 ensure successful clinical trial site participation
• Ensure best-practice sharing among Cell Therapy Operations and escalate onboarding impediments to leadership in a timely manner

Qualifications

• Required: CAR-T experience
• Required: Experience interacting with external partners (e.g., clinical site coordinators, external supplier relations, key account managers)
• Required: Hospital stakeholder management
• Required: Experience in pharmaceutical or hospital environment (medical, clinical, manufacturing, hospital, cell processing, or apheresis)
• Required: Demonstrated ability to engage on medical topics with confidence while balancing operational and strategic mindset
• Required: Demonstrated project management experience, with ability to manage several deliverables in parallel
• Preferred: Direct experience/knowledge related to cell apheresis, blood or tissue collection, or cryopreservation operations
• Required: Residence within territory, or within a 60-mile commuting distance; travel 60–80% across broad geography; must have a valid driver’s license

Education

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

Additional Requirements

• Travel: 60–80% across a broad geography
• Residence: Must reside within territory or within 60 miles of the territory border
• Driver's license: Must have a valid driver's license; driving is an essential function