AD, Cell Therapy Operations Manager - New York / Tri-State

Key Responsibilities:

• Partner and implement a One Team approach with commercial onboarding teams to support implementation of site onboarding as a supplier and end-user of commercial manufactured product. Support the efficient and effective qualification of key treatment and apheresis sites across North America to be in full compliance with Novartis policies and procedures
• Provide highly engaged site operations support to approved external site staff with a focus on providing guidance as well as continued training based upon approved Novartis messaging through customer facing with ordering physicians, clinical trial Primary Investigators, BMT coordinators, pharmacy, Infusion Nursing Teams, Clinical Trial Coordinators, as well as apheresis units and cell laboratory staff
• Responsible for ensuring that sites provide a high-quality consistent supply of starting material for the GMP manufacturing of Cell Therapy products through assessment, approval, initiation, and monitoring of incoming material batches from assigned territory sites. Ensure that sites comply with Novartis onboarding requirements and while ensuring continued oversite identifying and escalating needs for reassessment of sites in their ability to supply material in accordance with Novartis manufacturing specifications and requirements
• Conduct investigations in partnership with Apheresis Quality within the Novartis quality platform through assigned deviations related to incoming specifications, chain of identity breaches, and other related deviations of Novartis manufacturing specification as well as investigating manufacturing results when requested. Oversee the end-to-end process of deviations in close coordination with all relevant functions to ensure closure of deviation within the due date assigned to each deviation
• Deliver onsite support for first order, or any time after due to site inactivity; recent site deviations, or due to significant changes in Novartis processes requiring site refresher training. Onsite activities for first collection or any time after will be dependent upon assessments and can be related to cell collection, cell processing and/or shipment of starting material as well as the receipt of final product through the administration of the final product according to Novartis specifications and processes as well as local laws and regulations
• Support US functions in ‘localizing’ the center qualification framework according to country laws, regulations, Novartis Standard Operating Procedures including support in discussions with the relevant Health Authorities if applicable.
• Support consistent rollout of initial trainings including the Novartis Leukapheresis Manual, for Apheresis/Cell Lab/Pharmacy/Infusion Center (or Clinical Trial Handling Manual) and Final Mock Shipment by coordinating with local team and Customer Service Center team members
• Support Apheresis Quality on negotiation and maintenance of the Quality Apheresis Agreement in collaboration with legal teams and Strategic Account Managers
• Coordinate and guide a One Team approach with internal and external partners in clinical trial support across teams to include Novartis Medical, Novartis Trial Management, Clinical Customer Support, Apheresis Quality and assigned site Clinical Research Associates to ensure successful clinical trial site participation
• Ensure best practice sharing amongst Cell Therapy Operations and escalate impediments to onboarding in a timely manner to leadership

Essential Requirements:

• Education: Bachelor’s Degree required.  Business, medical or science education preferred
• Minimum of 7 years of experience in at least one of the following areas:
  • Experience in CAR-T
  • Interacting and supporting external partners (e.g., clinical site coordinator, external supplier relations, key account manager)
  • Hospital stakeholder management role
  • Working in a pharmaceutical or hospital environment (e.g., medical, clinical, manufacturing, hospital, cell processing, or apheresis)
• Demonstrated ability to engage on medical topics with confidence while balancing an operational and strategic mindset
• Demonstrated project management experience, with ability to manage several deliverables in parallel
• Direct experience/knowledge related to cell apheresis, blood or tissue collection, or cryopreservation operations preferred

• Candidate must reside within territory, or within a reasonable daily commuting distance of 60 miles from the territory border. Ability to travel 60-80% over a broad geography is required, with the ability to drive and/or fly within the territory. Must have a valid driver’s license.

Novartis Compensation Summary:

The salary for this position is expected to range between $138,600 and $257,400 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

Driving is an Essential Function of this Role: Meaning it is fundamental to the purpose of this job and cannot be eliminated. Because driving is an essential function of the role, you must have a fully valid and unrestricted driver’s license to be qualified for this role. The company provides reasonable accommodations for otherwise qualified individuals with medical restrictions if an accommodation can be provided without eliminating the essential function of driving.

COVID-19 Vaccine Policy (customer-facing roles only): 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 Eh.occupationalhealth@novartis.com

The individual hired for this role will be required to successfully complete certain initial training, including home study, eight (8) or fewer hours per day and forty (40) or fewer hours per week.