Night-Shift Senior Cell Therapy Manufacturing Lead

Bristol-Myers Squibb Company; Harvard (MA); On-site; USD 55,000 - 66,000; Full time

Benefits offered by this job

Comprehensive benefits

Wellbeing support

Flexible work arrangements

Job summary

Bristol Myers Squibb Company is seeking a Specialist, Lead Manufacturing Associate for Cell Therapy in Devens, MA. The role focuses on manufacturing operations in a cleanroom environment, following cGMP and SOPs to support solid cell therapy programs.

The ideal candidate has 4+ years in cGMP bioprocessing or cell therapy, a science/engineering degree, and the ability to work night shifts on-site with cross-functional teams and strict quality controls.

Qualifications

• 4+ years of experience in cGMP bioprocessing manufacturing, cell therapy manufacturing or relevant experience.
• Bachelor's in relevant science or engineering discipline, or equivalent in work experience.
• Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.
• Must be able to work assigned shift (Day, Night, Weekends and/or Holidays).
• Must be able to work in a cleanroom environment and perform aseptic processing.
• Must be comfortable being exposed to human blood components.
• Experience in cell therapy manufacturing, including Cell washing processes and automated equipment.
• Cell separation techniques and automated equipment.
• Cryopreservation processes and equipment.
• Aseptic processing in ISO 5 biosafety cabinets, 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 SOPs and batch records.
• Demonstrates strong practical and theoretical knowledge in their work.
• Completes documentation required by process transfer protocols, validation protocols, SOPs, and batch records.
• Solves complex problems; takes new perspectives using existing solutions.
• Performs tasks in a manner consistent with safety, quality, and GMP requirements.
• Sets up manufacturing areas and equipment; performs facility and equipment commissioning activities.
• Collaborates with support groups on recommendations and solving technical problems.
• Helps ensure the shift works effectively in a cross-functional team environment to complete production tasks.
• Collaborates closely with Shift Managers to ensure seamless pass down and communication of status.
• Supports investigations and writing manufacturing operating procedures.

Skills

cGMP knowledge

Cleanroom operations

Cell therapy manufacturing

Aseptic processing

Cryopreservation

Education

Bachelor's in science/engineering

Tools

Single-use bioreactors

Automated equipment

Cryopreservation equipment

Job description

Bristol Myers Squibb Company is seeking a Specialist, Lead Manufacturing Associate for Cell Therapy in Devens, MA. The role focuses on manufacturing operations in a cleanroom environment, following cGMP and SOPs to support solid cell therapy programs.

The ideal candidate has 4+ years in cGMP bioprocessing or cell therapy, a science/engineering degree, and the ability to work night shifts on-site with cross-functional teams and strict quality controls.