NIGHT SHIFT: Specialist, Lead Manufacturing Associate, Cell Therapy in Devens, MA

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.

BMS Cell Therapy Manufacturing seeks a Specialist, Lead Manufacturing Associate Cell Therapy that brings enthusiasm, intellectual curiosity, scientific rigor, and a desire to help drive novel programs. The candidate must be goal-oriented, flexible, and able to work efficiently with safety and quality in mind. We are searching for enthusiastic, and innovative individuals with a good understanding of good manufacturing practices to support routine manufacturing operations for Cell Therapy.

• Night Shift (6pm - 6am)
• Rotational schedule including holidays and weekends, onsite

• Execute operations described in standard operating procedures and batch records.
• Demonstrates strong practical and theoretical knowledge in their work.
• Completes documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records.
• Solves complex problems; takes new perspectives using existing solutions.
• Performs tasks in a manner consistent with the safety policies, quality systems, and GMP requirements. Completing training assignments to ensure the necessary technical skills and knowledge.
• Sets up manufacturing areas and equipment/fixtures. Perform facility and equipment commissioning activities.
• Collaborates with support groups on recommendations and solving technical problems.
• Help to ensure the shift works effectively in a team based, cross-functional environment to complete all production tasks required by shift schedule.
• Collaborates closely with Shift Managers to ensure seamless pass down and communication of operational status.
• Supports investigations.
• Identifies innovative solutions.
• Supports writing manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements.
• Training others on SOPs, Work Instructions to successfully complete manufacturing operations.
• Working with production planning with leadership to execute daily unit operations schedule that includes people, product, and material flow across multiple shifts.
• Work in a cleanroom environment and perform aseptic processing; maintain manufacturing environmental conditions (Non-Viable Particulate(s) and Viable microbial levels per controlled area classification specifications) by performing area disinfection regiment as required to meet global Health Authority requirements.

• Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.
• Must have the ability to work assigned shift (Day, Night, Weekends and/or Holidays).
• Must be able to work in a cleanroom environment and perform aseptic processing
• Must be comfortable being exposed to human blood components.
• Must be able to be in close proximity to strong magnets.
• Experience in cell therapy manufacturing, including Cell washing processes and automated equipment. Cell separation techniques and automated equipment. Cryopreservation processes and equipment.
• Experience in the following preferred Aseptic processing in ISO 5 biosafety cabinets, universal precautions for handling human derived materials in BSL-2 containment areas.
• Cell expansion using incubators and single use bioreactors

• 4+ years of experience in cGMP bioprocessing manufacturing, cell therapy manufacturing or relevant experience
• Bachelors in relevant science or engineering discipline, or equivalent in work experience.

• Stand and Walk - Required to stand/walk while operating manufacturing/computer equipment for several hours at a time,…