Operations Associate, Cell Therapy Supply Chain
Bristol Myers Squibb
4 hours ago
On-site
Devens, MA
Operations
Operations Associate, Cell Therapy Supply Chain — responsible for Supply Chain operations in direct support of the manufacture of Cell Therapy products, including:
- 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
- Material cleaning and kitting to ensure continuous supply of raw materials and consumables
- Warehouse activities including goods receipt, raw material put-away, and material disposal
Scope: Supply Chain day shift operations supporting commercial and clinical products manufactured at the Devens, MA Cell Therapy Facility.
Responsibilities
- Maintain safe work environment; wear required PPE
- Deliver right material to right location at right time while following GMPs and SOPs; recognize deviations
- Perform routine Material Operations: cleaning/replenishment, kit building, inventory cycle counting, and warehouse activities
- Support manufacture of commercial and clinical Cell Therapy products (storage, receipt of apheresis, cryogenic shipment packaging)
- Complete CGMP forms and/or paper/electronic batch records
- Perform SAP transactions per SOP (kits, replenishment, cycle count, bin-to-bin transfer)
- Use controlled documentation in a Document Management System; review incoming material paperwork
- Use GDocP and understand Chain of Identity (COI)
- Collaborate with Materials Operations, QC, QA, and Manufacturing; support deviations/CAPAs triage escalation
Work Requirements
- 12-hr shift (6PM–6AM); Panama schedule to cover 24-7-365 operations
- Commercial CGMP multi-product environment; standing/walking within and between grade-classified suites; ~90% time in operations area
- Follow PPE and controlled gowning requirements; may require respiratory protection and ability to wear a respirator
Knowledge and Skills (required/preferred)
- MS Office proficiency; strong written/verbal communication; ability to escalate concerns
- ERP experience; preferably SAP EWM
- QMS experience triaging events and executing deviations/CAPAs/workflows; preferably Infinity
- Kitting experience; handling cold chain biological materials; cryogenic (LN2) experience preferred
- Health authority experience (e.g., FDA) for audit support
- Electronic systems familiarity: SAP and MES (Syncade, DeltaV)
- Safety and Quality mindset; communicate critical info clearly/timely
- Experience working in operational suites with grade-level classifications
Basic Requirements
- High school Diploma/GED; Associate’s/Bachelor’s in relevant discipline preferred
- Preferred (not required) CPIM, CSCP, and/or CLTD certification
- Minimum 2+ years CGMP commercial biotechnology experience; Cell Therapy experience preferred
Compensation (explicitly stated)
- Devens, MA: US $30.81–$37.33 per hour (plus possible incentive cash/stock based on eligibility)
- 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
- Material cleaning and kitting to ensure continuous supply of raw materials and consumables
- Warehouse activities including goods receipt, raw material put-away, and material disposal
Scope: Supply Chain day shift operations supporting commercial and clinical products manufactured at the Devens, MA Cell Therapy Facility.
Responsibilities
- Maintain safe work environment; wear required PPE
- Deliver right material to right location at right time while following GMPs and SOPs; recognize deviations
- Perform routine Material Operations: cleaning/replenishment, kit building, inventory cycle counting, and warehouse activities
- Support manufacture of commercial and clinical Cell Therapy products (storage, receipt of apheresis, cryogenic shipment packaging)
- Complete CGMP forms and/or paper/electronic batch records
- Perform SAP transactions per SOP (kits, replenishment, cycle count, bin-to-bin transfer)
- Use controlled documentation in a Document Management System; review incoming material paperwork
- Use GDocP and understand Chain of Identity (COI)
- Collaborate with Materials Operations, QC, QA, and Manufacturing; support deviations/CAPAs triage escalation
Work Requirements
- 12-hr shift (6PM–6AM); Panama schedule to cover 24-7-365 operations
- Commercial CGMP multi-product environment; standing/walking within and between grade-classified suites; ~90% time in operations area
- Follow PPE and controlled gowning requirements; may require respiratory protection and ability to wear a respirator
Knowledge and Skills (required/preferred)
- MS Office proficiency; strong written/verbal communication; ability to escalate concerns
- ERP experience; preferably SAP EWM
- QMS experience triaging events and executing deviations/CAPAs/workflows; preferably Infinity
- Kitting experience; handling cold chain biological materials; cryogenic (LN2) experience preferred
- Health authority experience (e.g., FDA) for audit support
- Electronic systems familiarity: SAP and MES (Syncade, DeltaV)
- Safety and Quality mindset; communicate critical info clearly/timely
- Experience working in operational suites with grade-level classifications
Basic Requirements
- High school Diploma/GED; Associate’s/Bachelor’s in relevant discipline preferred
- Preferred (not required) CPIM, CSCP, and/or CLTD certification
- Minimum 2+ years CGMP commercial biotechnology experience; Cell Therapy experience preferred
Compensation (explicitly stated)
- Devens, MA: US $30.81–$37.33 per hour (plus possible incentive cash/stock based on eligibility)