Cell Therapy Center Operations Manager

6 mesi fa

Milano, Italia Novartis A tempo pieno

383903BR

**Cell Therapy Center Operations Manager**:
Italy

**About the role**

**About the Role**:
As Cell Therapy Center Operations Manager you will develop, coordinate and support implementation of the plan to train and qualify apheresis and treatment centers to be able to treat patients with the Novartis Oncology Cell Therapy products, both in commercial and clinical trial setting
You 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 to safely and efficiently treat patients with our products and supporting continuous operations improvements
You will also be responsible for ensuring high quality consistent supply of starting material for the GMP manufacturing of Cell Therapy products through assessment, approval, initiation, and monitoring of apheresis centers. Conduct investigations in case of deviations on starting material and oversight of the end-to-end process deviations in close coordination with all relevant functions

**Key responsibilities**:
Your responsibilities include, but are not limited to:
Center Qualification:

- Being responsible for supporting the efficient and effective qualification of key treatment and apheresis centers across Region Europe by coordinating with CTNMs, CTMMs/medical, market access, local QA, Apheresis QA and Customer Service Center in full compliance with EMA and local laws and regulations
- Support local country functions in ‘localizing’ the center qualification framework according to country laws and regulations, including support in discussions with the relevant Health Authorities if applicable
- 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
- Drive negotiation and maintenance of the Technical Apheresis Agreement in coordination with legal teams and Apheresis QA
- Verify that centers comply with applicable regulations / accreditations in coordination with Apheresis QA and local QA/DRA
- Support country legal team in the negotiation of supply, quality and consent agreements to the extent that it is required by those teams, in alignment with Legal CGT Region Europe

Center Operations Excellence:

- Being 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
- 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
- Lead continuous operational improvements plans in alignment with other functions and participate in Kymriah Experience Reviews (KERs) as well as other initiatives
- Support collection of KPI data to facilitate KERs and other operational performance reviews
- Develop and support implementation of new operational service offerings to improve the customer experience (e.g. educational programs, process solutions)
- Conduct Periodic Quality Reviews (PQRs) and manage follow-up of internal and external activities
- Support centers to scale-up and improve their CART operations and the implementation of spoke and hub models maximizing the access to patients
- Implement operationally new initiatives, updated training materials, processes and systems updates including strategic projects led by the Business Unit to improve operations in centers managing CAR-T
- Implement all regulatory/legal changes applicable related to the operations (RMP materials / SmPC changes, local changes, etc.)

Operational Deviations Management:

- Being responsible for ensuring that issues related to cellular starting material are appropriately evaluated, investigated and providing feedback and follow-up with the sites supplying the cell material. Closely working with the Lead Investigator during the investigations
- Keep oversight final product deviations/ issues and implement trainings plans liaising with all appropriate QA functions, manufacturing sites and logístical Hubs

**Commitment to Diversity & Inclusion**:

- We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

**Role Requirements**

**Essential Requirements**:

- University degree in Science and/or Medical or Business (Bachelor’s Degree Minimum)
- Minimum of 7 years external partner (supplier, customer, contractor) facing role experience and/or leadership experience in

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