Operations Associate, Cell Therapy - Devens MA

Operations Associate

Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please follow the next steps.

This Operations Associate role is responsible to perform Supply Chain operations in direct support to the manufacture of Cell Therapy products. These operations may include:

• Final storage of finished Cell Therapy drug product into cryogenic storage
• Receipt and processing of incoming patients' apheresis material
• Packaging of finished drug product into cryogenic shipper for shipment to patient
• Performance of material cleaning and kitting operations to ensure continuous supply of raw materials and consumables to support the manufacture of Cell Therapy products
• Execution of warehouse activities including goods receipt, raw material put-away, and material disposal

The scope of the role is for Supply Chain day shift operations in support of commercial and clinical products manufactured at the Devens, MA Cell Therapy Facility.

Shifts Available: 6am – 6pm, rotating schedule including holidays and weekends

Responsibilities will include, but are not limited to the following:

• General Work Activities
• Maintain a safe work environment and wear appropriate personal protective equipment (PPE)
• Deliver the right material, to the right location, at the right time while adhering to good manufacturing practices and standard operating procedures. The ability to recognize deviation from accepted practice is required.
• Perform routine Material Operations activities across the Cell Therapy Facility including cleaning and replenishment of materials, kit building, inventory cycle counting, and warehouse activities.
• Perform activities to directly support the manufacture of commercial and clinical Cell Therapy products:
• Final storage of finished Cell Therapy drug product into cryogenic storage
• Receipt and processing of incoming patients' apheresis material
• Packaging of finished drug product into cryogenic shipper for shipment to patient
• Documentation
• Complete CGMP forms and/or paper/electronic batch records
• Perform SAP transactions as required and per SOP to build kits, replenish materials, cycle count inventory, and transfer material between bin locations
• General understanding of working with controlled documentation in a Document Management System
• Review incoming material paperwork for incoming patient material (apheresis) receipt
• Use good documentation practices (GDocP) for all activities
• Demonstration and general understanding of the concept and importance of Chain of Identity (COI)
• Collaborate & Partner
• Interact effectively with Materials Operations Staff, Quality Control, Quality Assurance and Manufacturing.
• Collaborate with cross-functional employees & department managers to solve work-related problems and perform run-the-business activities
• Support the event escalation and triage process as it relates to deviations & CAPAs