Cell Therapy Operations Manager
Kerr Dental
full-time
Posted on:
Location Type: Remote
Location: New York • Pennsylvania • United States
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Salary
💰 $138,600 - $257,400 per year
About the role
- Develop, coordinate and support implementation of the plan to train and qualify apheresis and treatment centers to be able to treat patients with Novartis Oncology Cell Therapy products both in commercial and clinical trial setting
- Manage CAR-T center operations supporting qualified key staff including HCPs, infusion nurses, study nurses as well as apheresis unit and cell laboratory staff
- Partner and implement a One Team approach with commercial onboarding teams to support implementation of site onboarding as a supplier
- 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
- Responsible for ensuring that sites provide a high-quality consistent supply of starting material for the GMP manufacturing of Cell Therapy products
- 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
- Conduct investigations in partnership with Apheresis Quality within the Novartis quality platform through assigned deviations related to incoming specifications
- 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
- Support US functions in ‘localizing’ the center qualification framework according to country laws, regulations, Novartis Standard Operating Procedures
- Support consistent rollout of initial trainings including the Novartis Leukapheresis Manual
- Support Apheresis Quality on negotiation and maintenance of the Quality Apheresis Agreement in collaboration with legal teams
- Coordinate and guide a One Team approach with internal and external partners in clinical trial support across teams
Requirements
- 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
Benefits
- health, life and disability benefits
- 401(k) with company contribution and match
- generous time off package including vacation, personal days, holidays and other leaves
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
CAR-Tcell apheresisblood collectiontissue collectioncryopreservationproject managementGMP manufacturingclinical trial supportsite qualificationdeviation management
Soft Skills
stakeholder managementpartner collaborationoperational mindsetstrategic mindsetengagement on medical topicsguidance provisiontraining deliverycommunicationnegotiationteam coordination