NIGHT SHIFT: Senior Manufacturing Associate, Cell Therapy in Devens, MA

Bristol Myers Squibb • Devens, MA

6d • $34 - $41 • Onsite

About The Position

Bristol Myers Squibb is seeking a Senior Manufacturing Associate to support routine cell therapy manufacturing operations. The role calls for a goal-oriented and flexible individual who works efficiently with safety and quality in mind and brings enthusiasm, intellectual curiosity, scientific rigor, and a desire to help drive novel programs. The position is onsite in Devens, Massachusetts, on a rotating night shift from 6 p.m. to 6 a.m., including weekends and holidays.

The associate performs manufacturing operations in accordance with standard operating procedures (SOPs), batch records, cGMP requirements, safety policies, and quality systems. The role includes completing process transfer and validation documentation, supporting investigations, setting up manufacturing areas and equipment, assisting with commissioning, writing technically sound manufacturing procedures, and training colleagues. The associate also works with production planning to coordinate daily unit-operation schedules and people, product, and material flow across shifts.

Work takes place in a cleanroom and involves aseptic processing, maintaining controlled-area environmental conditions, and handling human blood components. The employee must wear personal protective equipment and cleanroom garments. Physical activities include standing and walking for several hours, handling loads up to 50 pounds, climbing, bending, kneeling, overhead reaching, and repetitive equipment setup and processing tasks.

Requirements

• High school diploma and at least 3 years of experience in cGMP bioprocessing manufacturing, cell therapy manufacturing, or relevant experience.
• Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.
• Ability to work the assigned shift, which may include nights, weekends, and holidays.
• Ability to work in a cleanroom environment and perform aseptic processing.
• Comfort handling human blood components.
• Ability to work in close proximity to strong magnets.
• Ability to meet the physical demands of the role, including standing and walking for several hours; carrying, lifting, pushing, or pulling up to 50 pounds; climbing; bending and kneeling; overhead reaching with items up to 25 pounds; and repetitive movement.
• Ability to wear required PPE and cleanroom garments daily.

Nice To Haves

• Bachelor's degree in a relevant science or engineering discipline and relevant experience.
• Experience in cell therapy manufacturing, including cell washing processes and automated equipment, cell separation techniques and automated equipment, and cryopreservation processes and equipment.
• Experience with aseptic processing in ISO 5 biosafety cabinets.
• Experience with universal precautions for handling human-derived materials in BSL-2 containment areas.
• Experience with cell expansion using incubators and single-use bioreactors.

Responsibilities

• Execute operations described in standard operating procedures and batch records.
• Apply strong practical and theoretical knowledge in assigned work.
• Complete documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records.
• Solve simple problems and apply new perspectives using existing solutions.
• Perform tasks consistently with safety policies, quality systems, and GMP requirements.
• Complete training assignments to develop necessary technical skills and knowledge.
• Train others on SOPs and work instructions so they can successfully complete manufacturing operations.
• Support investigations and identify innovative solutions.
• Assist with setup of manufacturing areas, equipment, and fixtures, and perform facility and equipment commissioning activities.
• Write technically sound manufacturing operating procedures that promote effective and efficient operations and comply with cGMP requirements.
• Work with production planning to execute the daily unit-operations schedule, including people, product, and material flow across multiple shifts.
• Perform aseptic processing in a cleanroom and maintain manufacturing environmental conditions, including particulate and viable microbial levels, through required area disinfection.

Benefits

• Potential eligibility for comprehensive benefit plans, including wellbeing support, retirement and financial protection benefits, and medical, dental, vision, life, and disability insurance.
• Non-exempt employees receive 160 hours of paid vacation annually for new hires, subject to manager approval, 11 paid company holidays, and 3 optional holidays.
• Depending on eligibility, additional time-off benefits may include paid sick leave, up to two paid volunteer days per year, summer-hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs.
• Eligible employees may receive an annual Global Shutdown between Christmas Day and New Year's Day.
• Potential eligibility for discretionary incentive cash and stock opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: High school or GED