Respond to and triage TCPCrequests from internal and collaborating organizations (CO). Serve as CO primary point of contact and manage internal and CO expectations and communications. Develop productive relationships with internal and CO and regulatory agencies and perform training of CO site personnel as necessary. Manage internal cost allocations, reimbursement strategies, billing efforts, and payment requests. Perform administrative GMP document control and SOP revisions as required. Assist in preparation of failure investigations and CAPA follow-ups as required. Perform and oversee shipment of cell products to clinical sites. Prepare and facilitate transfer of manufacturing and testing documents. Manage assigned TCPC projects by defining scope of project, creating work plans, determining resources, developing schedules, and monitoring progress.
- Bachelor’s degree in a Scientific or related field.
- Minimum five (5) years of related experience in a GxP environment, and encompassing cost recovery, budgeting, regulatory compliance, and vendor management.
- Experience in project management.