Night Shift Operations Associate, Cell Therapy Supply Chain
About the position
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 night shift operations in support of commercial and clinical products manufactured at the Devens, MA Cell Therapy Facility.
- Responsibilities
- 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. ,
- 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. ,
- 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). ,
- 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.
- Requirements
- High school Diploma / GED. Additional post-secondary education resulting in an Associate's or Bachelor's Degree in a relevant discipline is preferred. ,
- Minimum 2+ years of CGMP commercial biotechnology experience; Cell Therapy experience is preferred. ,
- Proficiency in MS Office applications. ,
- Strong written and verbal communication skills. ,
- Demonstrated experience to communicate problem statements and escalate concerns. ,
- ERP experience; preferably in SAP Extended Warehouse Management (EWM) transactions. ,
- Proven experience in triage of events and execution of deviations, CAPA, and other workflows in the Quality Management System (QMS); preferably in Infinity. ,
- Prior experience in kitting and delivery of raw materials and consumables to Manufacturing. ,
- Prior experience in handling of cold chain biological materials; prior experience with cryogenic storage (LN2) is preferred. ,
- Experience with health authorities (i.e., FDA) for audit support. ,
- Experience and familiarity with electronic systems including SAP, and manufacturing execution systems (MES) including Syncade and DeltaV. ,
- Safety and Quality mindset; proven ability to build a culture around these values and to communicate critical information clearly and in a timely manner to team and to manager as needed. ,
- Familiarity working in operational suites with various grade level classifications.
- Nice-to-haves
- Certification in CPIM, CSCP, and/or CLTD.
- Benefits
- Competitive benefits, services and programs that provide resources to pursue goals at work and in personal lives.
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