Specialist, Lead Clinical Manufacturing Associate, Cell Therapy

Bristol Myers Squibb•Devens, MA

2d•Onsite

About The Position

Bristol Myers Squibb is reimagining the future of cell therapy and is looking for driven individuals to join their Cell Therapy team. The Specialist, Lead Clinical Manufacturing Associate, Cell Therapy role requires enthusiasm, intellectual curiosity, scientific rigor, and a desire to drive novel programs. The ideal candidate will be goal-oriented, flexible, and able to work efficiently with safety and quality in mind. This role supports Clinical Manufacturing Start Up activities and direct manufacturing operations for Clinical Cell Therapy, with shifts available from Wednesday to Saturday, 7am to 5pm.

Requirements

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 working with human blood components.
Must be able to be in close proximity to strong magnets.
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.
GMP Compliance experience, knowledge of Data Integrity and ALCOA+ principles, and direct application of them.
Experience in cell therapy manufacturing, including cell washing processes, cell separation processes, cryopreservation processes, cell expansion processes using incubators and bioreactors, and automated equipment.
Must be able to travel to train and develop at other BMS Sites. Travel durations typically a week or less.

Nice To Haves

Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing is preferred.
Experience with aseptic processing in ISO 5 biosafety cabinets, universal precautions for handling human derived materials in BSL-2 containment areas is preferred.

Responsibilities

Performing Clinical patient process unit operations and supporting operations described in standard operating procedures and batch records.
Demonstrates strong practical and theoretical knowledge of work.
Completing documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records.
Performing tasks in a manner consistent with the safety policies, quality systems, and cGMP requirements.
Completing training assignments to ensure the necessary technical skills and knowledge.
Working in a cleanroom environment and performing aseptic processing; maintaining 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.
Referencing Batch Records, Standard Operating Procedures and Work Instructions to successfully complete manufacturing operations.
Solving complex problems; taking new perspectives using existing solutions.
Identifying innovative solutions.
Setting up manufacturing areas and equipment/fixtures.
Perform facility and equipment commissioning activities.
Working closely with Manufacturing Managers to ensure seamless pass undefined.
Working with production planning to execute daily unit operations schedule that includes people, product, and material flow across multiple shifts.
Helping ensure the shift works effectively in a team-based, cross-functional environment to complete all production tasks required by shift schedule.
Collaborating with support groups on recommendations and solving technical and operational problems.
Supporting development of manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements.
Supporting quality event investigations.
Any related tasks as required to contribute to a new startup facility.

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, and 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.