Operations Associate , Cell Therapy - Devens MA

VetJobs; Harvard (MA); On-site; USD 42,000 - 51,000; Full time

Job summary

Bristol Myers Squibb Devens Cell Therapy Facility is seeking staff for on-site warehouse and supply chain operations. The role supports commercial and clinical products, with emphasis on cryogenic storage, material handling, and batch documentation.

Shifts are 6am–6pm in a rotating schedule; involvement with cross-functional teams and adherence to GMP is required to ensure timely delivery of materials to production and patients in a fast-paced environment.

Qualifications

• CGMP forms/batch records are used.
• SAP transactions are performed per SOP to build kits and replenish materials.
• CoI and controlled documentation concepts are understood and used.

Responsibilities

• Final storage of finished Cell Therapy product in cryogenic storage.
• Receipt and processing of incoming apheresis material.
• Packaging of finished drug product for cryogenic shipment to patient.
• Perform routine material operations, kit building, cycle counting, and warehousing tasks.

Skills

Warehouse Operations

CGMP Documentation

SAP EWM

Cross-functional collaboration

Problem solving

Education

High School Diploma or GED

Associate degree preferred

Tools

SAP EWM

SAP

DeltaV

Syncade

MES

Job description

Job Description

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. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post. At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team.

Responsibilities

• 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

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

Minimum Education Required

High School/GED

Additional Qualifications / Responsibilities

Knowledge, Skills & Abilities:

• Proficiency in MS Office applications
• Strong written and verbal communication skills
• Demonstrated experience to communicate problem statements and elevate or solve 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

Minimum Requirements

• High school Diploma / GED. Additional post-secondary education resulting in an Associate’s or Bachelor’s Degree in a relevant discipline is preferred
• An equivalent combination of education, experience and training may substitute
• Preferred but not required: Certification in CPIM, CSCP, and/or CLTD
• Minimum 2+ years of CGMP commercial biotechnology experience; Cell Therapy experience is preferred

BMSCART

Compensation Overview

• Devens - MA - US: $30.81 - $37.33per hour
• City* Devens
• State* Massachusetts
• Salary Range >$100,000
• Affiliate Sponsor Bristol Myers Sqibb BMS