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…