Associate Scientist/Engineer, Manufacturing Technology

Bristol-Myers Squibb; United States; On-site; USD 90,000 - 120,000; Full time

Job summary

Bristol Myers Squibb is seeking an Associate Scientist/Engineer for Deven Manufacturing Science and Technology, Manufacturing Technology. You will serve as a process technical expert for large-scale cell culture and single-use manufacturing operations, delivering science-driven support to sustain GMP compliance and ensure reliable supply of life-changing therapies.

The role emphasizes deviation investigations, CAPA development, process monitoring, lifecycle management, and collaboration with

Qualifications

• Bachelor's degree in engineering, life sciences, biochemistry, biotechnology, or related field.
• 3–5 years of relevant experience in biopharmaceutical manufacturing, process engineering, manufacturing science, or technical operations.
• Working knowledge of commercial biologics drug substance manufacturing, including upstream and/or downstream operations.

Responsibilities

• Provide technical support for commercial biologics manufacturing operations, including deviation troubleshooting and process performance assessment.
• Contribute to investigations, CAPA development, and change controls.
• Support regulatory inspections, audits, and inspection-ready documentation.

Skills

Biopharmaceutical manufacturing

Data analysis

Process troubleshooting

Education

Bachelor's degree in engineering or life sciences

Job description

At Bristol Myers Squibb, our employees often ask, "Who are you working for?"-a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Join Bristol Myers Squibb's Devens Manufacturing Science and Technology- Manufacturing Technology team as a Associate Scientist/Engineer supporting commercial biologics manufacturing. In this role, you will serve as a process technical expert for large-scale cell culture and single-use manufacturing operations, providing science- and data-driven support to sustain GMP compliance, resolve complex process issues, and ensure reliable supply of life-changing therapies to patients.

As a key member of the Manufacturing Technology- Process Technical Operations team, you will serve as a technical support for commercial biologics manufacturing, leading and supporting deviation investigations, root cause analyses, CAPA development, process monitoring, continuous process verification, change controls, regulatory inspection readiness, and lifecycle management activities. You will apply process knowledge, manufacturing data, and scientific judgment to identify trends, resolve complex process challenges, improve process robustness, and support reliable GMP execution. In this role, you will collaborate closely with Manufacturing, Quality, MS&T, Validation, Analytical, Technical Product Teams, and site leadership to strengthen process performance, enable technology transfer, and advance continuous improvement across biopharmaceutical manufacturing. This opportunity is ideal for a technically strong, collaborative scientist who thrives in a fast-paced, data-driven environment and is motivated by solving complex problems that directly support BMS's mission to deliver patient-focused therapies.

Duties/Responsibilities

• 1. Provide technical support for commercial biologics manufacturing operations, including process deviation troubleshooting, process performance assessment, and identification of opportunities to improve process robustness and reliability.
• 2. Support root cause investigations for process deviations by contributing to data review, impact assessments, risk-based conclusions, and CAPA development.
• 3. Provide process technical support for internal audits, regulatory inspections, technical discussions, and health authority responses, including preparation of inspection-ready supporting documentation.
• 4. Provide on-call technical support for 24x7 large-scale cell culture and single-use biologics manufacturing operations, as needed.
• 5. Apply knowledge of cGMP expectations, BMS corporate standards, site procedures, regulatory requirements, and quality systems to investigations, change controls, technical assessments, and project deliverables.
• 6. Support process technology transfer, process validation, process performance qualification, post-approval changes, and preparation or review of CMC documentation.
• 7. Contribute to cross-functional technical projects supporting process robustness, yield improvement, digital manufacturing, operational excellence, and manufacturing performance objectives.
• 8. Evaluate process performance using manufacturing data, historical process knowledge, and basic statistical or data analysis tools to identify trends and recommend process improvements.
• 9. Author and review technical documents, including protocols, reports, SOPs, technical assessments, risk assessments, impact assessments, campaign summaries, and other GMP documentation.
• 10. Support change controls and related documentation to ensure technical accuracy, process alignment, GMP compliance, and regulatory consistency.
• 11. Collaborate with Manufacturing, Quality Assurance, Validation, Analytical, MS&T, Technical Product Teams, Supply Chain, Engineering, and site leadership to resolve technical issues and support timely execution of site priorities.
• 12. Contribute to a culture of safety, quality, accountability, continuous improvement, and scientific excellence by identifying risks, escalating concerns appropriately, and supporting practical, compliant solutions.

Qualifications

• Bachelor's degree in engineering, life sciences, biochemistry, biotechnology, or a related discipline; or equivalent combination of education and relevant experience. Typically requires 3-5 years of relevant experience in biopharmaceutical manufacturing, process engineering, manufacturing science, or technical operations.
• Working knowledge of commercial biologics drug substance manufacturing, including upstream and/or downstream unit operations, process control strategy, facility operations, and GMP manufacturing e