Mar 20, 2023

Job Description

4! The 4 essential elements that shape our culture: Inspired. Curious. Unbossed. Integrity. Our mission is to discover new ways to improve and extend peoples’ lives. Your passion to build, execute business plans to meet the sales goals, develop effective professional business relationships with Healthcare Professionals will help the world understand what these medicines do, why they matter and how Novartis is striving to reimagine medicine.

The Cell Therapy Center Operations Manager is to 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 (as CTL019/Kymriah and YTB323, PHE885) both in commercial and clinical trial setting; to lead 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; and is 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.

Your Responsibilities:
Your responsibilities include, but not limited to:

Center Certification
• Responsible for supporting the efficient and effective qualification of key treatment and apheresis centers coordinating with CAMs /medical, market access, local QA, Apheresis QA and Customer Service Center in full compliance with 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 Quality Assurance Agreement in coordination with legal teams and Apheresis QA; Verify that centers align 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.

• Deliver onsite support for 1st order process management including cell collection, cell processing and shipment of starting material as well as the reception through the administration of the final product according to Novartis specifications and processes as well as local laws and regulations; Develop and implement onboarding training plans for local customer facing teams; Coordinate the translation of Global Apheresis Operations materials for distribution to Apheresis Sites; Support to establish the Quality Management System in the on-boarding sites with apheresis QA.

Center Operations Excellence
• 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; Support collection of KPI data to facilitate 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 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 enhancing 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.

• Support to cultivate the Quality Management System culture collaborate with medical society and other partners (e.g; medical experts, health authorities and industry societies); Bring up apheresis site concerns to Global Apheresis Operations for resolution and applicability across all markets; Monitor quality of leukapheresis materials by reviewing all apheresis data forms to ensure adherence to specifications; Maintain site qualification records, including updating SQRA’s, site certifications and audits at specified frequencies.

Operational Deviations Management
• 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; Keep oversight final product deviations/ issues and implement trainings plans liaising with all appropriate QA functions, manufacturing sites and logistical Hubs; Ensure that all the activities performed according to Novartis Policy and Practices and appropriately follow P3, country legislation, and Pharmaceutical Industry Code & all internal regulations and processes.

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

Minimum requirements

What you’ll bring to the role:
• Bachelor degree in any Pharmacy/Sciences background; with MBA is preferable.

• Minimum of 7 years external partner (supplier, customer, contractor) facing role experience and/or leadership experience in healthcare; Working in a pharmaceutical or hospital GxP environment (e.g., Medical, clinical, manufacturing, hospital, cell processing, apheresis); Direct experience performing apheresis, blood or tissue collection, or cryopreservation operations preferred.

• Experience in interacting and supporting external partners (e.g., clinical site coordinator, external supplier relations, key account manager); Demonstrated ability to engage on deeply medical topics with confidence while balancing an operational approach; Demonstrated project management experience, with ability to handle several projects in parallel.

• Languages: Mandarin (fluent), English (fluent)

Why Novartis?

766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here at Novartis!
Research & Development
Full Time
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Cell Therapy Operations Manager

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