Senior Manufacturing Associate, Cell Therapy - Devens MA
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, goal orientation, and a strong focus on safety and quality. The associate performs work according to good manufacturing practices (GMP) and contributes to novel programs. The position is onsite in Devens, Massachusetts, with a 6 a.m.–6 p.m. rotating shift that includes holidays and weekends. Work takes place in a cleanroom and includes aseptic processing, maintaining environmental conditions within controlled-area specifications, and following a required area-disinfection regimen. The role involves operating and setting up manufacturing equipment and areas, completing manufacturing documentation, supporting investigations and commissioning activities, writing procedures, and coordinating with production planning to carry out daily schedules across multiple shifts. The associate also completes training and trains others on procedures and work instructions.
Requirements
- High school diploma and at least 3 years of experience in cGMP bioprocessing manufacturing, cell therapy manufacturing, or relevant experience.
- Ability to stand and walk while operating manufacturing or computer equipment for several hours at a time throughout the day.
- Ability to carry, lift, push, and/or pull up to 50 pounds several times a day.
- Ability to climb, including using stepladders in production areas or stairwells, several times a day.
- Ability to bend or kneel several times a day.
- Ability to reach overhead while handling production materials, files, or supplies weighing up to 25 pounds several times a day.
- Ability to move the head and neck while using computer applications and handling production equipment and materials.
- Ability to twist at the waist while setting up equipment.
- Ability to use arms, wrists, and hands repetitively while setting up equipment and processing.
- Ability to wear personal protective equipment and cleanroom garments daily, which may include safety shoes, safety glasses, aprons, face shields, lab coats, full-body gowns, hairnets, gloves, and hearing protection.
- Ability to work an onsite rotating 6 a.m.–6 p.m. shift that includes holidays and weekends.
Nice To Haves
- Bachelor’s degree in a relevant science or engineering discipline and relevant experience is strongly preferred.
Responsibilities
- Execute operations described in standard operating procedures and batch records.
- Complete documentation required by process transfer protocols, 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 necessary technical skills and knowledge.
- Train others on SOPs and work instructions to support successful 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-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, in accordance with controlled-area specifications and global Health Authority requirements.
- Perform area disinfection as required.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
High school or GED
