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.
Position Summary:
The MES Product Owner for Breyanzi is accountable for the end-to-end Manufacturing Execution System (MES) solution supporting the Breyanzi (CAR T cell therapy) manufacturing process at BMS, Bothell. This individual serves as the process and product expert who translates Manufacturing, Quality and Supply Chain requirements into clear, buildable specifications for MES engineers, leads a sub-team that includes junior and offshore engineers, and ensures that the resulting electronic batch records (EBRs) are compliant, efficient and inspection-ready. The role also acts as the sprint manager for the Breyanzi book of work, leading Agile delivery in Jira and reporting project status to stakeholders. The role requires hands-on MES experience (Syncade preferred), ownership of production deviations and CAPAs related to Breyanzi, and participation in the on-call rotation for L2 escalations. Must ensure GMP-regulated documentation processes and procedures are in place for all activities to meet quality and compliance standards. The candidate should have at least 5 years of experience in pharma/biotech, with specific expertise in Manufacturing, Quality, and Supply Chain systems and in Computer System Validation (CSV). Hands-on Breyanzi process knowledge is a strong advantage, and eMES development experience will stand out. Strong analytical, problem-solving, and communication skills are required.
Key Responsibilities:
Product Ownership – Breyanzi MES
- Act as Product Owner for Breyanzi from an MES standpoint: own the product backlog, prioritize enhancements and fixes, and maintain the roadmap in alignment with Manufacturing, Quality, Supply Chain, Facilities and Tech Transfer stakeholders.
- Serve as the Breyanzi process subject matter expert for MES; capture and document detailed requirements and translate them into User Requirements, Functional and Design Specifications and test cases.
- Bridge the gap between process requirements and engineering build, ensuring requirements are fully translated into complete EBRs in MES that meet GMP compliance and regulatory expectations (including 21 CFR Part 11 and data integrity principles).
Sprint and Project Management
- Lead Agile sprints in Jira for the Breyanzi book of work in a role similar to sprint manager, including sprint planning, backlog grooming, user story review and approval, sprint reviews and retrospectives.
- Maintain the project plan, including milestones, timelines, dependencies, risks and issues, and keep it current as scope and priorities change.
- Create and publish high-level project scorecards and status reports for IT and business leadership, covering progress against milestones, risks, and delivery health.
Team Leadership, Review and Training
- Lead the Breyanzi MES sub-team, including offshore resources who may be early in their careers; assign work, set expectations, and track delivery.
- Review design, configuration and test work performed by developers; provide guidance and feedback on quality, optimizations and enhancements to EBRs and MES recipes/workflows.
- Train and onboard new engineers on the Breyanzi manufacturing process and MES build standards to build team capability and reduce reliance on individuals.
Operations, Quality and Compliance
- Fully accountable for addressing production deviations and CAPA actions related to Breyanzi MES, including investigation, root cause analysis, corrective/preventive implementation and effectiveness checks.
- Provide primary application support for Breyanzi MES and serve on the on-call rotation to support L2 escalations for production issues.
- Maintain the validated state of the system through the change control process – creating changes in ServiceNow, obtaining pre-approval, executing/deploying changes, attaching evidence, closing tasks and obtaining post-approval.
- Participate in GMP validation activities including development and execution of IQ/OQ/PQ testing, and support software releases, audits and inspections.
- Identify and drive process and system improvements, standardization and reuse across Breyanzi EBRs and other manufacturing systems.
Qualifications & Experience:
Required Experience/Education
- Bachelor’s degree in Engineering, Life Sciences, Computer Science or related field, or equivalent experience
- 5+ years of relevant industry experience in biopharmaceutical/cell therapy manufacturing and/or manufacturing IT systems
- Strong working knowledge of the Breyanzi manufacturing process (or comparable autologous cell therapy process)
- Hands-on experience with Manufacturing Execution Systems, preferably Syncade, including EBR design and build
- Experience leading or mentoring engineers, including offshore or junior team members, and translating business requirements into technical specifications
- Experience managing production deviations, investigations and CAPAs in a GMP environment
- Experience with electronic document management and quality management systems, and with change control and CSV/validation practices in regulated industries
- Technical writing competency and GMP procedure writing
- Strong communication, collaboration and stakeholder management skills
- Willingness to participate in on-call rotation for L2 production support
Preferred Experience
- Prior experience developing in eMES
- Prior experience supporting commercial CAR T cell therapy manufacturing
- Experience with 21 CFR Part 11, GAMP 5 and data integrity requirements
We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.
Compensation Overview:
Bothell - WA - US: $108,650 - $131,655
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 adastaffingsupport@bms.com. 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/
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R1608189 : MES Engineer IT Systems