Operations Associate, Cell Therapy in Devens, MA

Operations Associate, Cell Therapy

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

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.

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

Work Requirements

• Shift is 12hr (6AM 6PM); Panama schedule to cover 24-7-365 operations
• Operate in a commercial CGMP multi-product environment
• Job requires standing and walking within and between grade classified suites
• Expectation of approximately 90% of time is spent in the operations space where the work is executed
• Don Personal Protective Equipment (PPE) and specialized gowning as required by procedures & signage. May work with hazardous material requiring additional PPE including respiratory protection (employee must be physically capable to wear a respirator)
• Must be able to follow all controlled gowning requirements for entrance to suites with various grade level classifications (Grade 8 and CNC)

Knowledge, Skills & Abilities:

• 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

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

Compensation Overview:

Devens - MA - US: $30.81 - $37.33 per hour

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit

Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.

Work-life benefits include:

Paid Time Off

• US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
• Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays

Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military