Associate, Patient Materials Operations, MSS

Role Summary

Handles patient material needs/requirements for CAR-T production per Standard Operating Procedures (SOPs) in controlled and/or classified environments under the supervision of Patient Materials Operations Management. Specialist must adhere to regulatory requirements while performing job functions. Job duties are performed within a team according to an assigned, production shift schedule. Communication of production deviations and assistance with quality investigations are required, as applicable. Location: Summit West - NJ - US.

Responsibilities

• Performs tasks for Cell Therapy products to support product Value Stream outputs according to Current Good Manufacturing Practices (cGMP's) following the current, approved Standard Operating Procedures (SOPs) and Work Instructions (WIs).
• Maintains timing according to the production schedule to ensure on-time logistics.
• Performs apheresis receipt of patient materials and prepares final product shipments for couriers.
• Executes receipt and discard of ex-US Peripheral Blood Mononuclear Cells (PBMC) and ex-US Cryopreserved Material (CMAT).
• Supports Sample Retrieval, Sample Movements, and Sample Storage.
• Supports transfers of Manufactured Goods to off-site facility.
• Supports manual and electronic batch record executions, deviation investigations, and closure of CAPAs.
• Ensures all documentation is correct and addresses procedural/documentation errors expeditiously and effectively.
• Work with management to ensure adequately trained personnel are available to perform all manufacturing activities.
• Records patient material handling data and information in a clear, concise, format according to proper GDPs.

Qualifications

• Bachelor's degree - OR Associate/ Medical Technical degree and 0-2 years of Manufacturing or Operations experience. - OR High School diploma/GED and 2-4 years of Manufacturing or Operations experience.
• Ability to problem solve with minimal supervision.
• Work in a team based, cross-functional environment to complete tasks required by shift schedule.
• Must be able to work in an environment with blood derived components. - Other duties may be assigned, as necessary.
• Available to work OT when business requires and willing to work staggered day shift hours.