Senior MES Program Delivery Lead

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a MES Program Delivery Lead to join our IOPS IT team, driving end-to-end delivery of our Manufacturing Execution System program across our global manufacturing sites. In this role, you will serve as a servant-leader and strategic problem-solver — aligning cross-functional teams, system integrators, and business stakeholders to deliver MES capabilities that are on scope, on schedule, and fully compliant — while collaborating with Manufacturing, Quality, Automation, and IT functions.

This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

• Location:
  
  Troy, New York, United States

• Work model:
  Monday - Friday 8am - 4:30pm, onsite

• Travel percentage: 10 - 20% to Ireland

• Own end-to-end MES program delivery across IOPS sites — spanning solution design, build, validation, deployment, and post-go-live stabilization of capabilities including electronic batch records, recipe and workflow management, and system integrations

• Lead and direct cross-functional delivery teams including internal staff, system integrators, and vendors; manage release planning, sprint ceremonies, dependencies, and resource allocation across the program

• Partner with business owners and senior stakeholders to define MES program scope, roadmap, deliverables, and timelines; manage budgets, workload balancing, and capacity planning

• Proactively identify, triage, and remove impediments; spot and mitigate technical, operational, delivery, and compliance risks across the program

• Ensure all MES deliverables meet GxP, ALCOA+, and 21 CFR Part 11 requirements by effectively applying SDLC/PMLC and Computer Software Assurance (CSA) methodologies

• Serve as the central communication bridge between business owners, executives, vendors, and the delivery team — reporting on program performance against schedule, budget, and quality targets

• Ensure delivery and validation documentation is complete, audit-ready, and stored appropriately; manage formal change control for any scope changes

• Lead and develop direct reports through monthly performance feedback meetings, ensuring training requirements are met and team capabilities continue to grow

• Demonstrated experience applying SDLC and Computer Software Assurance (CSA) methodologies, including risk-based approaches to validation of GxP computerized systems

• Experience delivering MES programs including electronic batch records, recipe management, and integrations with automation/SCADA, ERP, LIMS, and historian systems preferred

• Agile Scrum Master certification (CSM or PSM) preferred

• Strong stakeholder management and communication skills; able to translate complex technical delivery status into clear narratives for executive audiences

• Experience managing system integrators, vendor relationships, and cross-functional delivery teams in a regulated pharmaceutical or biotech environment preferred

• BS/BA in Information Technology or a related field

• Project Manager: 10+ years of experience in delivery leadership, program/project management, or IT management supporting MES platforms

• Senior Project Manager: 12 years of experience in delivery leadership, program/project management, or IT management supporting MES platforms

• May consider equivalent combination of education and experience; level determined based on qualifications

We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color,…