Cell Therapy Operations Manager - Remote

329559BR
Oct 11, 2021
USA

Job Description

Over 108,000. That’s how many US patients our oncology products touched in 2018. And while we’re proud of that, 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? We believe the answers are found when curious, courageous and collaborative people like you are empowered to ask new questions, make bolder decisions and take smarter risks

At Novartis, we are reimagining medicine to address some of society’s most challenging healthcare issues. We discover and develop breakthrough treatments and find new ways to deliver them to as many people as possible.

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.

Manage CAR-T center operations supporting qualified key staff including HCPs, 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.

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 key responsibilities:
Your responsibilities include, but are not limited to:
•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, including apheresis and/or cell processing
•Responsible for supporting the efficient and effective qualification of key treatment and apheresis centers across North America by coordinating with strategic account managers, medical, market access, local QA, Apheresis QA and Customer Service Center in full compliance with FDA and local laws and regulations
•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
•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
•Deliver onsite support for 1st order process management including apheresis cell collection(s), 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 support implementation of new operational service offerings to improve the customer experience (e.g. educational programs, process solutions)

Diversity & Inclusion / EEO

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.

Minimum Requirements

What you’ll bring to the role:
Minimum Requirements:

Educations: University degree in Science and/or Medical (Bachelor’s Degree Minimum);
Minimum of 7 years external partner (supplier, customer, contractor) facing role experience and/or leadership experience in healthcare
•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)
•Self-driven colleague able to work independently and collaboratively with highly functioning team
•Up to 60% travel within North America (NC, SC, TN, KY, AK)

Desirable requirements:
•Collaborative mindset to manage interactions with local cross-functional team and regional service teams. Ability to drive decisions in a quick and nimble way within high technology environments
•Direct experience performing apheresis, blood or tissue collection, or cryopreservation operations preferred

What you’ll receive:
Competitive salary, annual bonus, long term incentive for select levels, health insurance, paid vacation/holidays, potential flexible working arrangements, employee recognition program, employee referral program

Why consider Novartis?
769 million. That’s how many lives our products touch. And while we’re 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?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

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 re-imagine medicine.
ONCOLOGY
ONCOLOGY BU
USA
Charlotte, NC
Research & Development
Full Time
Regular
No
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329559BR

Cell Therapy Operations Manager - Remote

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