Biologics Manufacturing Process Scientist/Engineer

Biopharma Careers; Harvard (MA); On-site; USD 88,000 - 107,000; Full time

Benefits offered by this job

Comprehensive benefits

Flexible work models

Job summary

Bristol Myers Squibb in Devens, MA is seeking an Associate Scientist/Engineer for Manufacturing Technology to serve as a process expert in large-scale cell culture and single-use biologics operations. You will drive deviation investigations, CAPAs, and lifecycle activities to sustain GMP compliance and reliable product supply.

The role requires collaboration with Manufacturing, Quality, MS&T, Validation, and Analytical teams, contributing to process improvements and regulatory readiness in a

Qualifications

• Bachelor’s degree in engineering, life sciences, biochemistry, biotechnology, or related field; typically 3–5 years in biopharmaceutical manufacturing or technical operations.
• Experience with commercial biologics upstream/downstream operations and GMP manufacturing execution.
• Knowledge of SOPs, cGMPs, quality systems, regulatory expectations, and GMP documentation practices.
• Experience supporting process deviation investigations, CAPA development, risk-based decisions.
• Ability to review data, identify trends, and summarize findings with technical recommendations.
• Exposure to process transfer, validation, lifecycle management, post-approval changes, or inspection readiness is preferred.

Responsibilities

• Provide technical support for commercial biologics manufacturing operations and deviations.
• Lead root cause investigations and CAPA development.
• Support audits, regulatory inspections, and health authority responses, including documentation prep.
• Provide on-call technical support for 24x7 manufacturing operations.
• Apply cGMP knowledge and site standards to investigations and change controls.
• Support process technology transfer, validation, and lifecycle activities.
• Contribute to cross-functional projects for process robustness and efficiency.
• Analyze manufacturing data to identify trends and recommend improvements.
• Prepare or review GMP documentation and technical reports.

Skills

Process troubleshooting

Data analysis

Cross-functional collaboration

Technical documentation

Regulatory compliance

Education

Bachelor’s degree in engineering/life sciences

Tools

cGMP

Job description

Bristol Myers Squibb in Devens, MA is seeking an Associate Scientist/Engineer for Manufacturing Technology to serve as a process expert in large-scale cell culture and single-use biologics operations. You will drive deviation investigations, CAPAs, and lifecycle activities to sustain GMP compliance and reliable product supply.

The role requires collaboration with Manufacturing, Quality, MS&T, Validation, and Analytical teams, contributing to process improvements and regulatory readiness in a