Principal Product Owner, Manufacturing Execution

NCBiotech; North Carolina; On-site; USD 100,000 - 150,000; Full time

Job summary

Merck & Co. is seeking a Product Owner for Manufacturing Execution to lead the product strategy and delivery across multi-site biologics manufacturing. This high-impact role involves harmonizing MES platforms with DeltaV integration and ensuring audit readiness while improving yield and productivity.

The ideal candidate will have over 12 years of experience in biopharma manufacturing, including at least 3 years as a Product Owner. Key responsibilities include overseeing Agile delivery with teams and managing stakeholder communications effectively.

Qualifications

• 12+ years in biopharma manufacturing with 3+ years as Product Owner.
• Deep understanding of biologics DS operations and equipment readiness.
• Demonstrable leadership of multi-site MES/eBR initiatives integrated with DeltaV.

Responsibilities

• Own and evolve product strategy and roadmap for manufacturing execution.
• Lead Agile ceremonies for multiple scrum teams.
• Define and track KPIs; standardize workflows and recipes.

Skills

Leadership in biopharma manufacturing

Agile delivery

Stakeholder communication

Understanding of biologics operations

Experience with MES/eBR systems

Education

Equivalent education and experience

Tools

Jira

Azure DevOps

Job description

Position Overview

Fuel the future of biologics manufacturing. As the Product Owner, Manufacturing Execution, you will shape the vision, roadmap, and delivery of production execution across a multi-site biologics drug substance network. You’ll orchestrate Agile delivery with internal and vendor teams, harmonize MES platforms (Syncade and PAS‑X) with DeltaV integration (ISA‑88/95), and ensure compliant, right‑first‑time execution that measurably improves yield, lead time, and productivity.

This is a high‑impact role at the intersection of digital, operations, quality, and automation — perfect for a product leader who thrives in GxP environments and loves turning complex challenges into scalable, audit‑ready solutions.

Job Description

What you’ll do

• Own and evolve the product strategy and roadmap for manufacturing execution across all sites in partnership with solution architects and stakeholders.
• Translate business needs into epics/features/user stories with testable acceptance criteria and cGMP controls; maintain a transparent, value‑ranked backlog and manage dependencies across MES, DCS, interfaces, and plant networks.
• Lead Agile ceremonies for multiple scrum teams; define the Definition of Done (functional fit, Part 11/Annex 11, security, performance, data integrity); orchestrate UAT, validation documentation, release cutovers, and hyper‑care; ensure audit readiness and support inspections.
• Act as the voice of shop‑floor users and site leadership; drive decisions on recipe design, exception handling, review‑by‑exception, equipment states, and maintenance windows to minimize production impact—aligned to reference architectures and standards.
• Direct vendor teams and SOWs; track delivery performance; manage small to moderate product budgets and business cases; quantify value realization against committed outcomes.
• Define, track, and publish KPIs (lead time, yield, RFT, downtime); drive root‑cause and prevention; standardize recipes/workflows and expand automated data capture.
• Contribute to network standards for MES recipe design, data models, and integration patterns; ensure cybersecurity and segregation‑of‑duties controls with Automation/IT.
• And other duties as assigned.

Minimum qualifications (must‑have)

• 12+ years of experience in biopharma manufacturing or industrial technology, with 3+ years as a Product Owner/Manager or Business Analyst delivering GxP shop‑floor systems.
• Deep understanding of biologics DS operations (seed train, bioreactors, harvest/clarification, chromatography, UF/DF, buffer/media prep, CIP/SIP) and equipment readiness/maintenance on the shop floor.
• Demonstrated leadership of multi‑site MES/eBR initiatives (Syncade and/or PAS‑X) integrated with DeltaV; working knowledge of ISA‑88/95 and recipe orchestration.
• Agile delivery across multiple scrum teams and vendors; proficiency with Jira/Azure DevOps; excellent prioritization and stakeholder communication.
• Hands‑on experience with MES/eBR in regulated environments—preferably Syncade and/or PAS X—and integration with DeltaV DCS; working knowledge of ISA 88/95.
• Any combination of education and experience, which would provide an equivalent background to deliver against role expectations.

Preferred qualifications

• Proven experience harmonizing multi‑platform MES estates and establishing network standards; exposure to e‑logbooks/downtime tracking; familiarity with site automation standards, OT networks, and cybersecurity constraints.

Why you’ll love it here

• Shape network‑wide digital manufacturing capabilities with clear outcomes in yield, RFT, and cycle time.
• Lead meaningful change in a mission‑driven, compliant environment where quality and innovation go hand in hand.
• Collaborate with world‑class operations, quality, automation, and IT teams across sites and partners.

Ready to make a measurable impact at scale? Apply now and help us deliver right‑first‑time, every time.

This is a global position that will support all our FUJIFILM Biotechnologies sites. This position can be based at any of our locations around the globe. Benefits and compensation will be governed by the location that you are based from and considered your home site.

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre‑employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ([e-mail]).