Clinical Manufacturing Associate II, Cell Therapy in Devens, MA

Bristol Myers Squibb • Devens, MA

5d • $30 - $36 • Onsite

About The Position

The Clinical Manufacturing Associate II, Cell Therapy supports Clinical Manufacturing start-up activities and directs manufacturing operations for clinical cell therapy. The role calls for enthusiasm, intellectual curiosity, scientific rigor, flexibility, goal orientation, and a commitment to safety and quality. The Associate applies practical and theoretical manufacturing knowledge, follows good manufacturing practices, and contributes to a new startup facility.

The position performs clinical patient process unit operations in a cleanroom and carries out aseptic processing. It supports manufacturing schedules and the flow of people, products, and materials across multiple shifts, while maintaining controlled-area environmental conditions through required disinfection. The Associate completes production and validation documentation, follows batch records and controlled procedures, completes assigned training, collaborates with support groups to resolve technical and operational issues, and helps set up areas and equipment and perform commissioning activities.

The role requires working around human blood components and strong magnets, wearing personal protective equipment and cleanroom garments, and being available for the assigned shift, which may include days, nights, weekends, or holidays. Travel to other BMS sites for training and development may be required, typically for a week or less.

Requirements

• High school diploma and at least 2 years of experience in cGMP bioprocessing manufacturing, cell therapy manufacturing, or relevant experience.
• GMP compliance experience and knowledge and direct application of data integrity and ALCOA+ principles.
• 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 working with human blood components.
• Ability to work in close proximity to strong magnets.
• Ability to travel to other BMS sites for training and development; travel is typically a week or less.
• Ability to meet the described physical requirements, including standing and walking for several hours, handling loads up to 50 pounds, climbing, bending or kneeling, overhead reaching with items up to 25 pounds, and repetitive equipment setup and processing tasks.
• Ability to wear personal protective equipment and cleanroom garments daily.

Nice To Haves

• Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.
• Bachelor’s degree in a relevant science or engineering discipline.
• Experience in cell therapy manufacturing, including cell washing, cell separation, cryopreservation, cell expansion using incubators and bioreactors, and automated equipment.
• Experience with aseptic processing in ISO 5 biosafety cabinets and universal precautions for handling human-derived materials in BSL-2 containment areas.

Responsibilities

• Perform clinical patient process unit operations and supporting 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 consistent with safety policies, quality systems, and cGMP requirements.
• Complete training assignments to develop necessary technical skills and knowledge.
• Use batch records, standard operating procedures, and work instructions to complete manufacturing operations.
• Execute the daily unit operations schedule, coordinating 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.
• Collaborate with support groups on recommendations and resolution of technical and operational problems.
• Assist with setting up manufacturing areas, equipment, and fixtures, and perform facility and equipment commissioning activities.
• Perform related tasks as required to contribute to a new startup facility.

Benefits

• Wellbeing support, retirement and financial protection benefits, and medical, dental, vision, life, and disability insurance offerings, subject to plan terms and eligibility.
• Paid vacation or Flexible Time Off, depending on employee classification and eligibility.
• 11 paid company holidays annually.
• Three optional holidays for non-exempt employees, RayzeBio employees, and employees located in Puerto Rico.
• 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.
• Potential eligibility for discretionary incentive cash and stock opportunities.

What This Job Offers

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