367978BR
Mar 17, 2023
USA

Job Description

Every year, ~3,500 children are diagnosed with Acute Lymphoblastic Leukemia and ~25,000 adults are diagnosed with Diffuse Large B-Cell Lymphoma. 10% of these children, and 50% of these adults who do not respond to upfront therapies are faced with limited treatment options and low survival rates. Over the past few years, Cell & Gene therapies for these diseases have come to market, bringing new hope to patients, caregivers and HCP’s alike. There is still a large unmet need, and at Novartis we are reimagining medicine to continue to bring this innovative therapy to not only these patients, but those with other B-cell malignancies as well.

As an Associate Director, Cell Therapy 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 Novartis Oncology Cell Therapy products both in commercial and clinical trial setting. In this role, you will 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.

Your responsibilities include, but are not limited to:
• Support the efficient and effective qualification of key treatment and apheresis centers across your Midwest territory 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
• Ensure 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 assessment, selection, approval, initiation, and monitoring of hospitals/apheresis centers 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)
• 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.

This position can be based remotely anywhere in Illinois, Minnesota, South Dakota, North Dakota, Kansas, Missouri, Iowa, Wisconsin, or Nebraska (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. This position will require X% travel.

The pay range for this position at commencement of employment is expected to be between $144,000 and $216,000/year; however, while salary ranges are effective from 1/1/23 through 12/31/23, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

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:

Education: Bachelor’s degree in science and/or medical-related major as a minimum

Required Experience:
• Minimum of 7 years’ experience in an external partner-facing role (supplier or customer-focused in a hospital/healthcare system) with experience in apheresis or cell-processing
• Proven ability to successfully implement 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)
• Drive and ability to work independently and collaboratively with highly functioning team
• Collaborative mindset to manage interactions with local cross-functional team and regional service teams.
• Ability to travel up to 60% within the Midwest territory of Illinois, Minnesota, South Dakota, North Dakota, Kansas, Missouri, Iowa, Wisconsin, or Nebraska

Preferred:
• Direct experience performing apheresis, blood or tissue collection, or cryopreservation operations

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!

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

Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

While Novartis does not require vaccination for Covid-19 or proof of a recent negative test result for Covid-19 at this time, employees working in customer-facing roles must adhere to and comply with customers’ (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to [email protected].
PHARMA
ONCOLOGY
USA
Chicago, IL
Research & Development
Full Time
Regular
No
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367978BR

Associate Director, Cell Therapy Operations Manager - Midwest - Remote

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