Manufacturing Associate, CAR-T

About the Role

At Bristol Myers Squibb, we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-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.

Manufacturing Associates manufacture 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.

Schedule

Sunday - Wednesday (with every other Wednesday off), Onsite Night Shift, 5 p.m. - 5:30 a.m.

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 is required for most activities: welding, connections, and transfers, at minimum. Aseptic qualification is required.
• Weigh and measure in-process materials to ensure proper quantities are added/removed.
• Adhere to the production schedule ensuring on-time, internal production logistics.
• Record 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.
• Work in a team-based, cross-functional environment to complete production tasks required by shift schedule.
• Become a Subject Matter Expert (SME) and qualified trainer within a designated function of manufacturing.
• Maintain on-time completion of training assignments to retain necessary technical skills and process knowledge.
• Perform other tasks as assigned: continuous improvement projects, inspection readiness, right first-time initiatives, etc.

Requirements

• High School Diploma required. Bachelor's or associate degree preferred.
• 0-1 years of cGMP cell therapy manufacturing, bioprocessing manufacturing, or relevant experience.

Skills

• Basic understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique.
• 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.

Working Conditions

• Intermittent walking, standing, and sitting to perform job functions; however, ability to stand for extended periods of time may be necessary.
• Must be comfortable working with contained human blood components.
• Physical dexterity sufficient to use computers and documentation.
• Sufficient vision and hearing capability to work in the job environment.
• Ability to lift 25 pounds.
• Must have the ability to work in laboratories and controlled, enclosed, restricted areas.
• Cleanroom garments and personal protective equipment will be required in designated areas which cover head, parts of the face, core body, and legs/feet.
• Makeup, gum, nail polish, perfume/cologne, and other potential microbial sources are prohibited in restricted areas.
• Flexibility to don cleanroom garments and personal protective equipment (PPE).
• Cleanroom environment is an enclosed, restricted space, with assigned pressure and temperature conditions.
• Reagents, chemicals, and exposure to sanitization agents are expected.
• Routine exposure to human blood components.
• Restricted areas prohibit food, any outside materials such as cell phones, tablets, at a minimum.

Pay

Summit West - NJ - US: $27.83 - $33.72 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.

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.
• Work-life Benefits:
  • Paid Time Off for 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 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 needs, and an annual Global Shutdown between Christmas and New Year's Day.

All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.