Associate, Patient Materials Operation

Position Title: Associate, Patient Materials Operation

Direct Manager: Supervisor, Sample Management

Division: CTDO Quality Control

Duration: 06 Months

Location: Summit West, S-12, 07901

Shifts:

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. Associate 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.

Duties/Responsibilitie

• 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 facilities.
• Supports manual and electronic batch record executions, deviation investigations, and closure of CAPAs.
• Maintains timing according to the production schedule to ensure on-time logistics.
• Ensure 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.
• Able to solve problems with minimal supervision.
• Works 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.
• Perform other tasks as assigned.
• Available to work OT when business requires.
• Willing to work staggered day shift hours.

Job Safety Requirements & Essential Physical Demands

• Ability to safely handle chemical disinfectants, flammable materials, and hazardous chemicals
• Ability to independently don, doff, and wear required PPE during work shift (e.g., sterile scrubs, socks, gloves, safety glasses, safety shoes).
• Ability to handle liquid nitrogen (LN?) and cryogenically cooled materials during cryopreserved shipment preparation, loading, and transport while wearing required cryogenic PPE.
• Ability to lift, carry, push, and pull shipping containers, cryo-carts, totes, and LN? shippers, including team lifts to 50 lbs. per person from mid-thigh to shoulder height.
• Ability to safely operate powered scissor lifts or similar material handling equipment in accordance with site procedures.
• Ability to appropriately respond to alarms and emergency conditions related to cryogenic materials, shipment preparation, and material handling.
• Ability to use step stools to reach and handle materials

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.