Cell Therapy Manufacturing Specialist II

Bristol Myers Squibb; Harvard (MA); On-site; USD 41,000 - 50,000; Full time

Benefits offered by this job

Comprehensive benefits

Flexible work options

On-site at Devens MA

Job summary

Bristol Myers Squibb in Devens, MA is seeking a Clinical Manufacturing Associate II, Cell Therapy to perform unit operations within cGMP guidelines and support startup activities for a new facility.

The role requires experience in cell therapy manufacturing, cleanroom operations, aseptic processing, and the ability to work day, night, weekends, and holidays. You will document batch records, follow SOPs, and collaborate across teams across multiple shifts.

Qualifications

• Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing is preferred.
• Willingness to work Day/Night/Weekends/Holidays as needed.
• Ability to work in a cleanroom and perform aseptic processing.
• Comfortable handling human blood components.
• Must travel to train and develop at other BMS sites.

Responsibilities

• Perform clinical patient process unit operations per SOPs and batch records.
• Maintain knowledge of process transfer protocols and QC requirements.
• Complete documentation per SOPs and batch records.
• Identify and implement innovative solutions to improve operations.
• Work in a cleanroom and maintain controlled environmental conditions.
• Assist in startup facility setup and equipment commissioning.
• Collaborate with support groups to solve technical and operational issues.

Skills

cGMP knowledge

Cell Therapy

Aseptic processing

Cleanroom

Documentation

Shift flexibility

Education

High school diploma

Bachelor's degree preferred

GMP compliance experience

Cell therapy manufacturing experience

Tools

ISO 5 biosafety cabinets

Bioreactors

Cryopreservation equipment

Job description

Bristol Myers Squibb in Devens, MA is seeking a Clinical Manufacturing Associate II, Cell Therapy to perform unit operations within cGMP guidelines and support startup activities for a new facility.

The role requires experience in cell therapy manufacturing, cleanroom operations, aseptic processing, and the ability to work day, night, weekends, and holidays. You will document batch records, follow SOPs, and collaborate across teams across multiple shifts.