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

Role Summary

This field-based and remote role supports key accounts in the New York / Tri-State area. You will develop and coordinate training and qualification of apheresis and treatment centers to safely and efficiently treat patients with Novartis Oncology Cell Therapy products in commercial and clinical trial settings. You will manage CAR-T center operations, supporting staff across HCPs, infusion nurses, trial nurses, apheresis unit staff and cell laboratories, and drive continuous operations improvements.

Responsibilities

• Partner and implement a One Team approach with commercial onboarding teams to support site onboarding as a supplier and end-user of commercially manufactured product; qualify key treatment and apheresis sites across North America in full compliance with Novartis policies and procedures
• Provide highly engaged site operations support to approved external site staff, offering guidance and ongoing training based on approved Novartis messaging to ordering physicians, clinical trial Principal Investigators, BMT coordinators, pharmacy, Infusion Nursing Teams, Clinical Trial Coordinators, and apheresis units and cell laboratories
• Ensure 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; ensure ongoing onboarding compliance and identify needs for reassessment of sites
• Conduct investigations with Apheresis Quality within the Novartis quality platform for deviations related to incoming specifications, chain of identity breaches, and related deviations; oversee end-to-end deviation handling to closure by due date
• Deliver onsite support for first order or after periods of site inactivity, deviations, or changes requiring refresher training; onsite activities may involve cell collection, cell processing and/or shipment of starting material and receipt of final product according to Novartis specifications and local laws
• Support US functions in localizing the center qualification framework according to country laws, regulations, SOPs, and engage in discussions with Health Authorities as applicable
• Support rollout of initial trainings including Leukapheresis Manual, Apheresis/Cell Lab/Pharmacy/Infusion Center manuals and Final Mock Shipment, coordinating with local teams and Customer Service Center teammates
• Support Apheresis Quality in 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 site participation
• Ensure best practice sharing among Cell Therapy Operations and escalate onboarding impediments to leadership in a timely manner

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 (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

Education

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

Additional Requirements

• Residency: Candidate must reside within the territory, or within a reasonable daily commuting distance of 60 miles from the territory border
• Travel: Ability to travel 60–80% over a broad geography is required
• Other: Valid driver’s license required