Lead Manufacturing Associate, Cell Therapy Manufacturing

Bristol Myers Squibb•Devens, MA

9h•Onsite

About The Position

Bristol Myers Squibb is reimagining the future of cell therapy and is seeking a Specialist, Lead Manufacturing Associate Cell Therapy. This role requires enthusiasm, intellectual curiosity, scientific rigor, and a desire to drive novel programs. The ideal candidate is goal-oriented, flexible, and able to work efficiently with safety and quality in mind. This position supports routine manufacturing operations for Cell Therapy, with a focus on good manufacturing practices. The role involves working in a cleanroom environment and performing aseptic processing, maintaining environmental conditions, and executing operations according to standard operating procedures and batch records. The position also involves collaborating with various teams, supporting investigations, and training others.

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

Nice To Haves

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

Responsibilities

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.

Benefits

Medical, pharmacy, dental, and vision care.
BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
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.
Flexible time off (unlimited, with manager approval)
11 paid national holidays
160 hours annual paid vacation for new hires with manager approval
11 national holidays
3 optional holidays
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 needs
Annual Global Shutdown between Christmas and New Years Day.