Principal Product Owner, Manufacturing Execution
About the role
Fuel the future of biologics manufacturing. 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.
Responsibilities
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 hypercare; 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.
Requirements
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.
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.