Senior MES Program Delivery Lead

Regeneron Pharmaceuticals, Inc.

City of Troy (NY)

On-site

USD 108,000 - 206,000

Full time

4 days ago
Be an early applicant

Get a reply from this employer

Your resume and cover letter, tailored to exactly what they’re hiring for.

Get past ATS filters

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a MES Program Delivery Lead to drive end-to-end MES delivery across IOPS sites, aligning cross-functional teams, system integrators, and stakeholders to stay on scope and on schedule.

You will apply SDLC, CSA, and GxP controls, manage budgets and risks, lead delivery teams, and ensure audit-ready documentation and strong executive reporting across global manufacturing operations. Travel 10-20% to Ireland as needed.

Qualifications

  • Bachelor-level degree in information tech or related field required.
  • 10+ years of delivery leadership in MES or related IT disciplines.
  • Equivalents considered based on qualifications.

Responsibilities

  • Own end-to-end MES program delivery across IOPS sites including design, build, validation, deployment, and post-go-live support.
  • Lead cross-functional teams, system integrators, and vendors; manage release planning, sprints, dependencies, and resource allocation.
  • Define MES scope, roadmap, deliverables and timelines; manage budgets and capacity planning.
  • Identify and mitigate technical, operational, delivery and compliance risks across the program.
  • Ensure all MES deliverables meet GxP, ALCOA+, and 21 CFR Part 11 through SDLC/PMLC and CSA methodologies.
  • Serve as communication bridge to stakeholders; report on schedule, budget, and quality; ensure audit-ready documentation.

Skills

MES delivery
SDLC
CSA
GxP
Agile Scrum Master

Education

BS/BA in Information Technology or related field

Job description

Team: Industrial Operations & Product Supply

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.

When & there:
  • Location: Troy, New York, United States
  • Travel percentage: 10 - 20% to Ireland
Discover your role:
  • 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
This role requires:
  • 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

Does this sound like you? 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, 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.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: 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, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/ . For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$108,000.00 - $206,100.00

What people ask before they join

We take hiring seriously — because finding the right person for our mission matters as much to us as finding the right company matters to you. Our process is thorough by design: we want every new hire to feel confident they've found a place where their work truly matters, and we want to be just as confident we've found someone who'll thrive here. It's a two-way conversation, not a one-way interview.

Curious what that looks like step by step? Check out How We Hire .

Part of the team
Where You'll Make an Impact

Here, you’ll collaborate with teams across regions to help move our mission forward.

We invest in your health and stability so you can focus on making meaningful impact. Below is a highlight of benefit programs that may be available to you, depending on your country of employment, role, etc.

Medical, dental and vision insurance
Life insurance and disability coverage
Global wellness support & benefits access
Paid time off, personal/flexibility hours and holiday leave

Showing slide 1 of 4 (group 1 of 2)

Our hiring process

From application to your first day — here's how it works.

1. EXPLORE

Browse open roles at careers.regeneron.com, filtered by department, location or category. You can also create a job alert or join our Talent Community to get matched with new openings as they post.

2. APPLY
3. CONNECT

We review your application and if your experience is a match, we'll reach out to start the conversation. Some roles include a seminar or technical exercise — we'll always tell you in advance.

4. DECISION

After interviews and careful consideration by the hiring team, we'll follow up either way. If you're selected, we'll walk you through the offer — compensation, benefits, and start date.

5. WELCOME

Once you accept, we'll help you prepare for day one - from paperwork and office details to relocation when applicable. You'll have the support you need to start strong.

Be part of what’s next in science

Hear about new opportunities and stories across our teams.

Get your free, confidential resume review.

or drag and drop your file here.

Similar jobs

Similar jobs worth comparing

Senior Manager, GMP OT Applications
Senior Manager, GMP OT Applications

Regeneron Pharmaceuticals, Inc. • New York (NY)

On-site
USD 121,000 - 231,000
Sr Staff Fill/Finish MFG Engineer
Sr Staff Fill/Finish MFG Engineer

Regeneron • City of Rensselaer (NY)

On-site
USD 126,000 - 206,000
Senior EHS Specialist
Senior EHS Specialist

Regeneron Pharmaceuticals, Inc. • Town of East Greenbush (NY)

On-site
USD 80,000 - 131,000
Automation Engineer
Automation Engineer

Regeneron Pharmaceuticals, Inc. • City of Rensselaer (NY)

On-site
USD 75,000 - 123,000
Supervisor, GMP Warehouse (Days)
Supervisor, GMP Warehouse (Days)

Regeneron • New York (NY)

On-site
USD 80,000 - 131,000
Biotech Production Coordinator
Biotech Production Coordinator

Regeneron Pharmaceuticals, Inc. • City of Rensselaer (NY)

On-site
USD 34,000 - 53,000
Senior Manager Clean Environments
Senior Manager Clean Environments

Regeneron • City of Rensselaer (NY)

On-site
USD 126,000 - 206,000
Senior Manager HR Business Partner
Senior Manager HR Business Partner

Regeneron • New York (NY)

On-site
USD 120,000 - 180,000
Process Development Engineer I
Process Development Engineer I

Regeneron Pharmaceuticals, Inc. • Village of Tarrytown (NY)

On-site
USD 85,000 - 110,000
Supervisor Quality Control (Overnights)
Supervisor Quality Control (Overnights)

Regeneron • City of Saratoga Springs (NY)

On-site
USD 80,000 - 131,000