Director, GCC & V2V Operations, ASPAC/EMEA

This leader will support the Patient Journey from start through delivery of finished goods. The organization supports both the Clinical & Commercial Patients in the early scheduling of the patient through patient infusion. Communication of capacity, apheresis collection, logistics requirements, manufacturing status, and material readiness is provided by the team in support of the process. Execution of Chain of Identity (CoI) and Chain of Custody (CoC) requirements is also embedded in the team’s responsibilities.

Global set up of local networks to support Clinical Trials, then Commercial patients/hospitals are required. Process improvements to support the movement to the Commercial Supply Chain’s demands is also critical for product / process success. 

As we embark on launch in new regions/countries, review of requirements vs. global standard will be required.  Review of Processes, set up of master data, system support (global systems + regional) will be required.

Leadership around site activation principals, scheduling, and planning will be required.

Reviews of capacity (logistics, apheresis / cryo slots, etc.) will be required and will depend on partnership with both internal and external partners.

Tasks/Duties/Responsibilities

• Support Day to Day Finished Product Delivery through End to End process support with local teams & partners in meeting local supply/demand requirements.

• Identify & Lead Process Improvements & KPI Reviews with Hospital Sites.  Support Training & Onboarding of Hospital Sites within region. 

• Lead Regional Escalation Communication on any issues that impact patient manufacturing or release.

• Maintain regional ownership of COC/COI requirements for patient material.  Drive process improvements & innovation, as appropriate.

• Manage Headcount & Budget Requirements while maintaining strong talent pipeline and development of future leaders

• Support partnerships (internally & externally) that help ensure CARVYKTI is the preferred cell therapy based on experience, not only clinical efficacy.

Other responsibilities:

• Lead a team of Cell Collection, Vein to Vein Managers and Planners that will support the development of local strategies to support CAR-T as well as the planning and execution of CoC/CoI, logistics, and patient support needed to deliver Clinical Trials & Commercial product.

• Leading efforts to meet regulatory requirements in support of Chain of Custody (CoC) and Chain of Identity (CoI) for all material movement for personalized medicine products produced

• Leading Cross Functional conversations about where and how the Supply Chain will support Certified Sites across Regions

• Building Strong Alliances with Regional Marketing Leads, Clinical Supply Chain partners, and JSC Supply Chain partners

• Building Capabilities to support Scheduling and Customer Service needs in partnership with internal plant & clinical/commercial partners.

• Challenging the status-quo, driving innovative approaches and concepts, embedding business and customer focus in team activities

• Ensure effective planning to secure resources for regional needs and communicate to all stakeholders

• Delivering capabilities that support a positive customer experience through technology & non-technology platforms that will be regionally specific.

• Develops, shapes and analyzes key performance indicators of process (over time cross site & region) to help deliver on key process insights, driving improvement, and shaping performance.