Associate Scientist/Engineer, Manufacturing Technology

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

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 work effectively in cross-functional teams, manage multiple priorities, communicate technical information clearly, and escalated issues appropriately.
• Strong analytical, problem-solving, collaboration, and written communication skills.

Compensation Overview

Devens - MA - US: $88,190 - $106,863

The starting pay range(s) listed above is for full‑time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.

Benefits

Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).

U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.

Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.

Depending on eligibility, employees may also have access to additional time‑off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year’s Day.

U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits

How We Work

Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail] . Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

For roles based in Los Angeles County only: If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If this posting is missing required information required by local law or incorrect, contact BMS at [e-mail] with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

R1605874 : Associate Scientist/Engineer, Manufacturing Technology