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: Northern CA, OR, UT and WA with travel up to 60% of the time. This is a remote position with a preference for the candidate to live within the assigned geographic area (Northern CA, UT, OR, WA).
Your responsibilities include, but not limited to:
• Responsible for supporting the efficient and effective qualification of key treatment and apheresis centers across Northern CA, UT OR and WA, 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
What you’ll bring to the role:
• University degree in Science and/or Medical or Business (Bachelor’s Degree Minimum) required • Minimum of 7 years external partner (supplier, customer, contractor) facing role experience and/or leadership experience in healthcare required • Experience in at least one of the following areas: o Interacting and supporting external partner (e.g. clinical site coordinator, external supplier, key account manager o Hospital partner management o Pharmaceutical or hospital GxP environment (e.g. medical, clinical, manufacturing, hospital, cell processing, apheresis) • Proven ability to successfully execute a complex process in a cross functional matrixed environment and to interact with medical and administrative personnel at all levels and in large numbers (~15-20 stakeholders per site) and engage on deeply medical topics with confidence while balancing an operational mindset • Direct experience performing apheresis, blood or tissue collection, or cryopreservation operations preferred • Ability to travel and cover large multistate geography territories, at least 60% travel required, based on geography and territory. Live within assigned geographic area preferable (Northern CA, UT, OR, WA).
You’ll receive: Competitive salary, annual bonus, long term incentive for select levels, health insurance, paid vacation/holidays, potential flexible working arrangements, subsidized dining facilities, employee recognition scheme.
Why consider Novartis? 769 million. That’s how many lives our products touched in 2020. And while we are proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives? If you are ready to be part of our journey to reimagine medicine get in touch.
Imagine what you could do at Novartis!
Commitment to Diversity & Inclusion Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
We are Novartis. Join us and help us reimagine medicine.
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.