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

Role Summary

Field-based and remote opportunity supporting key accounts in New York and Pennsylvania. This role has no relocation assistance; travel and working hours will be defined by the hiring manager. As an Associate Director, Cell Therapy Operations Manager, you will develop, coordinate, and support implementation of training and qualification of apheresis and treatment centers to treat patients with Novartis Oncology Cell Therapy products both in commercial and clinical trial settings. You will manage CAR-T center operations supporting qualified staff including healthcare professionals, infusion nurses, study nurses, and apheresis unit and cell laboratory staff, ensuring centers operate safely and efficiently and supporting 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. 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 ongoing training based on approved Novartis messaging to 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 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 onboarding compliance and identify needs for reassessment of sites’ ability to supply material per manufacturing specs.
• Conduct investigations in partnership with Apheresis Quality within the Novartis quality platform related to deviations, chain of identity breaches, and other related deviations; oversee end-to-end deviation management to closure by due date.
• Deliver onsite support for first order or as needed due to site inactivity, recent deviations, or significant process changes requiring site refresher training; onsite activities may include cell collection, processing, shipment of starting material, and administration of the final product according to Novartis specifications and local regulations.
• Support US functions in localizing the center qualification framework according to country laws and Novartis Standard Operating Procedures, including support in discussions with 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 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 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

• Education: Bachelor’s Degree required; business, medical or science education preferred.
• 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.