Manufacturing Associate, CAR-T, Manufacturing Operations

Bristol Myers Squibb•Summit, NJ

7d•$28 - $34•Onsite

About The Position

Bristol Myers Squibb is 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. The Manufacturing Associate, CAR-T, Manufacturing Operations (Harvest) is responsible for manufacturing human blood derived components per Standard Operating Procedures (SOPs) in a controlled, cGMP cleanroom environment under the supervision of Manufacturing Management. Manufacturing Associates adhere to regulatory requirements while performing job functions. Job duties are performed within a team according to an assigned, production shift schedule. Communication of production deviations and assistance with quality investigations are required, as applicable.

Requirements

Knowledge of cGMP/FDA regulated industry.
Basic mathematical skills.
General understanding of cGMPs.
Technical writing capability.
Proficient in MS Office applications.
Background to include an understanding of biology, chemistry, medical or clinical practices.
High School Diploma required.
0-1 years of cGMP cell therapy manufacturing, bioprocessing manufacturing, or relevant experience.

Nice To Haves

Bachelor's or associate degree preferred.

Responsibilities

Perform set-up and operation of equipment to support production of blood component lots through cell culture, harvest, and cryopreservation.
Support deviation investigations and write ups as needed. Support on time closure of any assigned CAPAs within the designated shift.
Aseptic technique and gowning is required for most activities: welding, connections, and transfers, at minimum. Aseptic ISO7/ISO5 qualification is required.
Weighs and measures in-process materials to ensure proper quantities are added/removed.
Adheres to the production schedule ensuring on-time, internal production logistics.
Records production data and information in a clear, concise, format according to proper GDPs.
Perform all tasks in a manner consistent with site safety policies, quality systems, and GMP requirements.
Works in a team based, cross-functional environment to complete production tasks required by shift schedule.
Motivated, team consciousness individuals are needed to fulfill job requirements.
Become a SME and qualified trainer within a designated function of manufacturing.
Supervision will be managed by the shift Supervisor or designated Team Lead.
Maintain on time completion of training assignments to maintain the necessary technical skills and process knowledge.
Performs other tasks as assigned: continuous improvement projects, inspection readiness, right first-time initiatives, etc.
Ensures all documentation is correct and addresses procedural/documentation errors expeditiously and effectively.
Records patient material handling data and information in a clear, concise, format according to proper GDPs.
Able to problem solve with minimal supervision.
Other duties may be assigned, as necessary.
Available to work OT when business requires.

Benefits

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.
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
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
an annual Global Shutdown between Christmas and New Years Day.