Associate Scientist/Engineer, Manufacturing Technology

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 execution. Knowledge of SOPs, cGMPs, quality systems, regulatory expectations, and GMP documentation practices in a regulated manufacturing environment. Experience supporting process deviation investigations, root cause analysis, impact assessments, CAPA development, and risk-based technical decision-making. Ability to review process data, identify trends, apply basic statistical or data analysis tools, and summarize findings into technically sound recommendations. Experience supporting process monitoring, continuous process verification, annual product quality review, campaign summary, validation, or process performance qualification activities. Exposure to process technology transfer, process validation, lifecycle management, post-approval change support, regulatory filing support, or inspection readiness activities is preferred. Ability to support troubleshooting, optimization, and technical assessment of biologics manufacturing processes, equipment, and/or unit operations. Ability to wo