Specialist, CAR-T Production Planning and Scheduling

About the position

The primary responsibility of the Specialist, CAR-T Production Planning and Scheduling is to schedule operations supporting clinical and commercial CAR-T manufacturing at the Summit West NJ site. The role will require significant collaboration across internal and external functions to ensure on-time fulfillment of final product. Ideal candidate will have demonstrated ability to balance multiple competing priorities, manage projects, and build supply chain best practices.

Responsibilities

• Create and maintain detailed site plans for operations including apheresis receipt, material kitting, media process intermediates, manufacturing, and drug product shipments.
• Point of contact for the Manufacturing Operations team to provide support, facilitating operational continuity and addressing issues as they arise.
• Monitor and report KPI's.
• Work with the Systems and Technology, Manufacturing Sciences and Technology team on system implementations and continuous improvement projects.
• Collaborate with IT Business Partners in support of modeling and scheduling simulation implementations.
• Support the S&OP process by providing site level manufacturing capacities and operational capabilities.
• Maintain and update site procedures for CAR-T material management functions.

Requirements

• Bachelor's degree required. An equivalent combination of education, experience and training may be considered.
• 2 to 3+ years of relevant work experience required, preferably in a regulated pharmaceutical manufacturing environment in Cell Therapy, Cryopreservation, or Manufacturing Operations.
• 1+ years of experience supporting ERP systems (preferably Oracle EBS and SAP).
• Strong ability to work independently in a fast-paced environment with changing priorities.

Nice-to-haves

• Understanding of cell culture, cryopreservation, purification, and aseptic processing or lab techniques.
• Knowledge of cGMP/Pharmaceutical regulations.
• Understanding of ERP systems and analytics/reporting tools.
• Experience in MS Office applications.
• Proficient written and verbal communication skills.
• Proficient presentation development and delivery skills.
• Technical writing capability.
• Ability to work independently for extended periods of time.
• Ability to work as part of a team.
• Ability to develop and provide training on various functions.
• Ability to creatively solve both routine and complex problems.
• Ability to provide on-call support in case of emergent issues.

Benefits

• Competitive benefits, services and programs that provide resources to pursue goals at work and in personal lives.