Job ID 317226BR
Position Title Cell Therapy Operations Manager (DC & VA)
Job Description
Your Responsibilities:
Up to 27 potential launches are expected in the next 5 years at Novartis, 10 in the next two years within the Oncology franchise. If serving patients is your passion, if professional growth is what you are searching for this may be the opportunity for you! In this world of digital and technological transformation, we must ask our-selves this: how can we continue to improve and extend even more people’s lives?
The Cell Therapy Operations Manager will be responsible for developing, coordinating and supporting implementation of the plan to train and qualify apheresis and treatment centers to treat patients with our products, both in commercial and clinical trial setting. She/he will manage CAR-T center operations supporting qualified key staff including HCPs, transplant/CAR-T coordinators, pharmacy, infusion nurses, study nurses as well as apheresis unit and cell laboratory staff, ensuring that the centers are operating safely and efficiently. He/she will be responsible for the consistent supply of high quality starting material for the GMP manufacturing of Cell Therapy products through assessment, approval, initiation, and monitoring of apheresis centers. The Cell Therapy Operations Manager will conduct investigations into start material and end-to-end process deviations in close collaborations with all relevant functions. The ideal candidate will build positive relationships with local country teams and key center partners.
The Cell Therapy Operations Manager will be required to support the following territories: DC and VA with travel up to 60% of the time.
Your responsibilities include, but not limited to:
• Responsible for supporting the efficient and effective qualification of key treatment and apheresis centers across Northern CA, by coordinating with SAMs, medical, market access, local QA, Apheresis QA and Customer Service Center in full compliance with FDA and local laws and regulations
• Support consistent rollout of initial trainings including Leukapheresis manual, product ordering management and cancellation/product replacement/credit request, patient consent, Risk Management Plan procedures for Cell Lab/Pharmacy/Infusion Center (or Clinical Trial Handling Manual) and Mock Shipment by coordinating with local team and Customer Service Center team
• Verify that centers follow applicable regulations / accreditations in coordination with Apheresis QA and local QA and ensure that all activities are performed according to Novartis Policy and Practices, follow P3, country legislation, Pharmaceutical Industry Code and all internal regulations and processes
• Responsible for ensuring high quality consistent supply of human cells and tissues (HCT) intended for use as manufacturing starting material in GMP manufacturing of cell therapy products through selection, approval, initiation, and monitoring of hospitals/sites that will collect and process HCT
• Responsible for ensuring that issues related to cellular starting material are evaluated, investigated with feedback and follow-up to the sites supplying the cell material. Working closely with the Lead Investigator during the investigations
• Lead continuous operational improvements plans in alignment with other functions and participate in Kymriah Experience Reviews (KERs) as well as other initiatives
• Possess in depth knowledge of the customer/marketplace, key dynamics and company policies as well as up to date knowledge of key competitors and their likely strategies
• Develop and implement onboarding training plans for local customer facing teams. Ensure best practice sharing 
(20min delay)