Night Shift: Cell Therapy Manufacturing Lead

Bristol-Myers Squibb Company; Harvard (MA); On-site; USD 61,000 - 73,000; Full time

Job summary

Bristol Myers Squibb seeks a Lead Manufacturing Associate, Cell Therapy, for night shift operations in Devens, MA. The role requires strong cGMP knowledge, aseptic processing, and experience in cell therapy manufacturing.

You will work in a cleanroom, perform critical process steps, and collaborate with cross-functional teams to ensure compliance and quality. Responsibilities include executing SOPs, documenting batch records, and contributing to SOP development and training.

Qualifications

• Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.
• Ability to work assigned shift (Day, Night, Weekends and/or Holidays).
• Cleanroom environment experience and aseptic processing.
• Comfort with human blood components and proximity to magnets.

Responsibilities

• Execute operations per SOPs and batch records.
• Document and validate process transfer protocols and batch records.
• Work with cross-functional teams to troubleshoot and optimize production.
• Set up manufacturing areas and perform commissioning activities.
• Support writing manufacturing SOPs and training others.

Skills

cGMP regulations

Cleanroom work

Aseptic processing

Cell therapy manufacturing

Automated equipment

Cryopreservation

BSL-2 handling

Single-use bioreactors

Education

Bachelor's degree in science/engineering

Tools

Biosafety cabinets ISO 5

Automated equipment

Single-use bioreactors

Job description

Bristol Myers Squibb seeks a Lead Manufacturing Associate, Cell Therapy, for night shift operations in Devens, MA. The role requires strong cGMP knowledge, aseptic processing, and experience in cell therapy manufacturing.

You will work in a cleanroom, perform critical process steps, and collaborate with cross-functional teams to ensure compliance and quality. Responsibilities include executing SOPs, documenting batch records, and contributing to SOP development and training.