Cell Therapy Operations Lead

Janssen Inc., a Johnson & Johnson company, is recruiting for a Cell Therapy Operations Lead, located in Toronto, Canada.

The CTOL is the primary point of contact for CAR-T treatment centres for all matters related to the provision of JJIM CAR-T products. CTOL provides the connection between commercial operations and medical matters as a member of the local CAR-T medical team. Its field-related activities include:

- Managing end-to-end site set-up & certification activities and site lifecycle maintenance requirements to ensure site and staff readiness to successfully manage cell therapy orders; Updating training material in accordance with Health Canada requirements;
- Delivering and supporting the coordination of up-front and ongoing education and training of sites for systems, protocol, and policies that support order fulfillment based on site readiness (e.g., modify training requirements for existing clinical sites); including in-person order and technology utilization support with accompanying educational materials;
- Informing and supporting order tracking and operations coordination post-order placement and communicates cell journey status with the appropriate internal and external stakeholders; supporting the end-to-end JJIM CAR-T utilization experience for sites; identifying process improvement opportunities based on customer feedback on order journey, policies and procedures;
- Ensures operational performance and compliance with obligations, understands key supply chain processes such as planning, delivery and activation, and confirms labeling and documentation obligations. Coordinates apheresis nurses, CAR-T coordinators, research coordinators and vein-to-vein team to communicate site requirements regarding production, space availability, ensures the right information and support is provided for adverse event reporting, and tracking; Managing site performance data and activity (including slot allocation and utilization), and customer feedback data and funnel up to larger team;
- Assess severity and urgency of unforeseen issues related to the ordering and manufacturing of the CAR-T product; manage issue resolution for orders in a timely manner (e.g., rescheduling, cancellations, returns, and all other exceptions); escalate and facilitate timely closure for all customer inquiries; assisting the communication between various internal and external stakeholders in the event of an out-of-spec product; supporting the treatment centre in administering the OOS product through either clinical trial or Open Label Individual Protocol;
- Stay up-to-date with technical, medical, and compliance-related training on CAR-T and the CAR-T related therapeutic area(s).
- Act in full compliance with relevant local and regional regulations and SOPs, in particular: Data Protection, Advertising Rules, Corporate SOPs, PV; ready to support any audit or inspection by local health authorities.
- Acting as the key person liaison person between the various internal stakeholders (e.g. batch advocate, local medical director, local release team) in the event of an out-of-spec product.
- Working across different Canadian time zones; ready to provide after-hour support for treatment sites that can extend 2 hours beyond the normal working hours.

The CTOL is a local role dedicated to CAR-T, helping to deliver a best-in-class customer experience through the CAR-T process. Provides training to the healthcare facility during the qualification process.

Acting as the primary contact for the healthcare facility on all matters related to the provision of JJIM CAR-T product(s). Assisting treatment centers with case management, supporting treatment site onboarding on the order management IT platform, and ensuring the right stakeholders receive the right information. Works with site stakeholders, especially the CAR-T coordinator, apheresis team, physician, and pharmacist to coordinate all CAR-T-related operations. Hosts regular meetings with qualified healthcare facilities on available manufacturing slots to ensure clinically appropriate allocation and maximal utilization.

Supports patient intake by verifying the completeness of the information, as well as the process of ordering, cell processing, cell transport, and delivery. Collaborates with internal stakeholders to resolve issues with ordering or manufacturing in accordance with company policies. Supports rescheduling and cancellations as needed, proactively communicates with treatment centers, uses the IT platform, and responds to their requests.

Enables synchronization of patient and cell journey, proactively checks and facilitates order fulfillment by collaborating with JJIM stakeholders, coordinates cell pickup and delivery based on location preferences in collaboration with the Supply Chain department. Communicates regularly about cell status location and timelines.

Acts as the primary liaison person between the various internal stakeholders (e.g. batch advocate, local release tea