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About the Role

Regeneron is seeking a MES Program Delivery Lead to drive end-to-end delivery of the Manufacturing Execution System program across global manufacturing sites. This role involves aligning cross-functional teams, system integrators, and business stakeholders to deliver compliant MES capabilities, contributing to a science-driven organization making a difference to patients worldwide.

Responsibilities

Own end-to-end MES program delivery across IOPS sites, including solution design, build, validation, deployment, and post-go-live stabilization.
Lead and direct cross-functional delivery teams, manage release planning, sprint ceremonies, dependencies, and resource allocation.
Partner with business owners and senior stakeholders to define MES program scope, roadmap, deliverables, and timelines.
Proactively identify, triage, and remove impediments and mitigate risks across the program.
Ensure all MES deliverables meet GxP, ALCOA+, and 21 CFR Part 11 requirements using SDLC/PMLC and Computer Software Assurance (CSA) methodologies.
Serve as the central communication bridge between business owners, executives, vendors, and the delivery team.
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 performance feedback, ensuring training requirements are met and team capabilities grow.

Requirements

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.
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.
10+ years of experience in delivery leadership, program/project management, or IT management supporting MES platforms.
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.

Skills

MES program delivery
Solution design
Build
Validation
Deployment
Post-go-live stabilization
Electronic batch records
Recipe and workflow management
System integrations
Release planning
Sprint ceremonies
Dependency management
Resource allocation
Roadmap definition
Deliverable definition
Timeline management
Budget management
Workload balancing
Capacity planning
Impediment identification and removal
Risk mitigation
GxP compliance
ALCOA+ compliance
21 CFR Part 11 compliance
SDLC/PMLC methodologies
Computer Software Assurance (CSA) methodologies
Communication
Stakeholder management
Agile Scrum Master certification (CSM or PSM) preferred
Automation/SCADA integration
ERP integration
LIMS integration
Historian system integration

Location

Troy, New York, United States

Work Type

Onsite
Full-time

Experience Level

Project Manager: 10+ years
Senior Project Manager: 12 years

Education Level

BS/BA in Information Technology or a related field

Salary/Compensations

$108,000.00 - $206,100.00

Benefits

Annual bonuses or other incentive plans
Equity awards
Pension or retirement benefits
401(k) company match
Health and wellness programs
Fitness centers
Insurance benefits (e.g. medical, dental, vision, life and disability)
Paid time off
Family support benefits

About the Company

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases.
We are committed to building a workplace with an inclusive culture.
We believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site.

Equal Opportunity

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law.
Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.