Senior Manufacturing Associate, Cell Therapy in Devens, MA

Bristol Myers Squibb • Devens, MA

2d • $34 - $41 • Onsite

About The Position

Bristol Myers Squibb is seeking a Senior Manufacturing Associate, Cell Therapy, to support routine cell therapy manufacturing operations. The role calls for a goal-oriented, flexible individual with enthusiasm, intellectual curiosity, scientific rigor, and a working understanding of good manufacturing practices who can work efficiently with safety and quality in mind.

The position performs manufacturing operations according to standard operating procedures and batch records, supports process transfer and validation activities, and helps maintain compliance with cGMP requirements and applicable safety and quality systems. Work includes cleanroom and aseptic processing, equipment and area setup, documentation, training, investigations, and coordination with production planning to carry out unit-operation schedules across shifts. The role is onsite in Devens, Massachusetts, on a rotating 6 a.m.–6 p.m. shift that includes weekends and holidays.

The work involves standing and walking for several hours at a time; carrying, lifting, pushing, or pulling up to 50 pounds; climbing, bending, kneeling, overhead reaching, twisting, and repetitive use of arms, wrists, and hands. Employees must wear personal protective equipment and cleanroom garments. The role may involve exposure to human blood components and close proximity to strong magnets.

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 days, nights, weekends, and/or holidays.
• Ability to work in a cleanroom environment and perform aseptic processing.
• Comfort with exposure to human blood components.
• Ability to work in close proximity to strong magnets.
• Physical ability to stand and walk while operating manufacturing or computer equipment for several hours at a time.
• Physical ability to carry, lift, push, and/or pull up to 50 pounds several times a day.
• Physical ability to climb, bend, kneel, reach overhead with materials up to 25 pounds, twist, and perform repetitive arm, wrist, and hand movements as required by the work.
• Ability to wear personal protective equipment 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.
• Experience with cell separation techniques and automated equipment.
• Experience with 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.
• Demonstrate 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 by applying existing solutions from new perspectives.
• Perform work consistently with safety policies, quality systems, and GMP requirements.
• Complete training assignments to develop required technical skills and knowledge.
• Train others on SOPs and work instructions so they can successfully complete manufacturing operations.
• Support investigations.
• Identify innovative solutions.
• Assist with manufacturing area and equipment/fixture setup 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 daily unit-operation schedules, including people, product, and material flow across multiple shifts.
• Work in a cleanroom and perform aseptic processing.
• Maintain manufacturing environmental conditions, including non-viable particulate and viable microbial levels within controlled-area classification specifications, by performing area disinfection as required.

Benefits

• Comprehensive benefit plans, including wellbeing support, retirement and financial protection benefits, and medical, dental, vision, life, and disability insurance offerings, subject to plan terms and eligibility.
• Potential eligibility for additional discretionary cash incentives and stock opportunities.
• For non-exempt employees: 160 hours of paid vacation annually for new hires, subject to manager approval; 11 paid company holidays; and 3 optional holidays.
• Depending on eligibility, 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.

What This Job Offers

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