Lead Manufacturing Associate, Cell Therapy Manufacturing

Bristol Myers Squibb • Devens, MA

1d • $40 - $49 • 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. We are looking for enthusiastic and innovative individuals with a good understanding of good manufacturing practices to support routine manufacturing operations for Cell Therapy. This is an onsite position with available shifts including Night Shift (6pm – 6am) and a rotational schedule that includes holidays and weekends.

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 bioprocessing 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

• 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 include: 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
• Based on eligibility, additional time off for employees 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 Years 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level