Cell Therapy: Clinical Manufacturing Associate II

Bristol Myers Squibb EU Policy; Harvard (MA); On-site; USD 85,411,000 - 103,320,000; Full time

Job summary

Bristol Myers Squibb is hiring a Clinical Manufacturing Associate II, Cell Therapy in Devens, MA, to join a team focused on startup manufacturing operations for clinical cell therapy. The role requires cGMP knowledge, ability to work in cleanrooms and across shifts, and collaboration across functions to support start-up activities and manufacturing operations.

You will perform unit operations per SOPs, maintain batch records, and ensure safety and quality in a fast-paced environment.

Qualifications

• High school diploma with 2+ years in cGMP bioprocessing or cell therapy manufacturing.
• Bachelor's degree in science or engineering preferred.
• GMP, Data Integrity and ALCOA+ principles knowledge.
• Experience with aseptic processing in ISO 5 biosafety cabinets is preferred.
• Experience with cell therapy manufacturing processes.
• Ability to work across Day/Night/Weekends/holidays.

Responsibilities

• Perform clinical patient process unit operations per SOPs and batch records.
• Document per transfer protocols and batch records.
• Solve simple problems and reference procedures for manufacturing operations.
• Support in setting up manufacturing areas and equipment.
• Work in cleanroom and maintain GMP compliant environment.
• Collaborate with support groups to resolve technical issues.
• Complete training to gain necessary skills.
• Operate daily unit operations schedule across shifts.

Skills

cGMP knowledge

Cleanroom work

Cell therapy manufacturing

Shift flexibility

Blood components handling

Travel willingness

Safety compliance

Education

High school diploma + 2+ years cGMP

Bachelor's in science/engineering preferred

GMP compliance knowledge (ALCOA+)

Job description

Bristol Myers Squibb is hiring a Clinical Manufacturing Associate II, Cell Therapy in Devens, MA, to join a team focused on startup manufacturing operations for clinical cell therapy. The role requires cGMP knowledge, ability to work in cleanrooms and across shifts, and collaboration across functions to support start-up activities and manufacturing operations.

You will perform unit operations per SOPs, maintain batch records, and ensure safety and quality in a fast-paced environment.