Sr Manufacturing Associate, Cell Therapy - Devens MA

Military Spouse Corporate Career Network•Devens, MA

1d•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 enthusiasm, intellectual curiosity, scientific rigor, flexibility, and a strong focus on safety, quality, and good manufacturing practices. The associate executes procedures and batch records, supports investigations and facility commissioning, helps prepare manufacturing areas and equipment, writes technically sound operating procedures, and works with production planning to carry out unit operations across multiple shifts. The position involves cleanroom work and aseptic processing, including maintaining environmental conditions in accordance with area classification specifications and health authority requirements. The role is onsite in Devens, Massachusetts, with a rotating 6 a.m.–6 p.m. shift that includes weekends and holidays.

Requirements

High school diploma and at least 3 years of experience in cGMP bioprocessing manufacturing, cell therapy manufacturing, or relevant work 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 and perform aseptic processing.
Comfort with exposure to human blood components.
Ability to work in close proximity to strong magnets.
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.
Ability to perform the physical activities described, including standing and walking for several hours, handling loads up to 50 pounds, climbing, bending, kneeling, overhead reaching with loads up to 25 pounds, twisting, and repetitive use of arms, wrists, and hands.
Ability to wear required personal protective equipment and cleanroom garments daily.

Nice To Haves

Bachelor’s degree in a relevant science or engineering discipline and relevant experience is strongly preferred.
Aseptic processing in ISO 5 biosafety cabinets.
Experience with 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.
Complete documentation required by process transfer and validation protocols, standard operating procedures, and batch records.
Perform tasks in accordance 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 and identify innovative solutions.
Assist with setting up manufacturing areas, equipment, and fixtures.
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 operations 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, by performing area disinfection as required.