AD, Cell Therapy Operations Manager

• Build strong relationships with internal and external territory key stakeholders to provide best in class customer support. Partner and execute a One Team approach with commercial onboarding teams, including Strategic Account Managers, Kymriah CARES and Apheresis Quality to support implementation of site onboarding as a supplier and end-user of commercial manufactured product.
• Coordinate and guide a One Team approach adhering to GCP with internal and external stakeholders in clinical trial support & site onboarding 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.
• 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.
• Ensure 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.
• 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. Oversight of 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
• Ensure best practice sharing amongst Cell Therapy Operations and escalate impediments to onboarding in a timely manner to leadership.
• Conduct Periodic Quality Reviews of sites in accordance with Novartis Standard Operating Procedures and meet all timelines associated (PQRs). Manage follow-up of internal and external activities in collaboration within the Novartis One Team approach.
• Complete internal training as a Certified Novartis Investigator and function fully within the Novartis quality tracking program, in partnership with the Apheresis Quality team to ensure all investigations and/or quality events to site activities are completed/evaluated while providing follow-up including, but not limited, to onsite refresher training to the sites supplying the cell material as appropriate.
• Partner with internal stakeholders in relation to management of final product deviations/issues and implement trainings plans

The AD, Cell Therapy Operations Manager requires up to 60-70% travel to cover the territory of Ohio, Michigan, Indiana, West Virginia and Pennsylvania. This role can be based remotely anywhere in the U.S., if the employee is based near a major airport (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) is defined by the hiring manager.

Essential Requirements:                             

• Bachelor’s degree required in science and/or medical, business, or nursing
• Minimum of 7 years external partner (supplier, customer, contractor) facing role experience and/or leadership experience in healthcare which may include Pharmaceuticals
• Experience in at least one of the following areas: 1) interacting and supporting external partners (e.g., clinical site coordinator, external supplier relations, key account manager); 2) hospital stakeholder management role or a customer facing role in pharmaceuticals; or 3) working in a pharmaceutical or hospital GxP environment (e.g., Medical, clinical, manufacturing, marketing, market access, patient services, hospital, cell processing, or apheresis
• Demonstrated ability to engage and train groups/individuals with confidence while balancing an operational and strategic mindset
• Proven project management experience, with ability to manage several deliverables in parallel
• Comfort with navigating interactions with various subject matter experts across medical and administrative personnel at all levels and in large numbers
• Strong negotiating, observational, listening skills to engage stakeholders at all levels with humbleness and openness
• Ability to travel up to 60%-70% within North America and the ability to arrange travel quickly to meet customer/patient needs onsite at certified treatment centers. Flexibility to work outside regular business hours, including evenings and weekends to attend meetings/conferences as well as site support due to transport of material from different time zones

Field role with a company car: 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.

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.

The pay range for this position at commencement of employment is expected to be between $151,200 and $226,800/year; however, while salary ranges are effective from 1/1/24 through 12/31/24, 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.