Principal Product Owner, Manufacturing Execution

• Own and evolve the product strategy and roadmap for manufacturing execution across all sites
• Translate business needs into epics, features, and 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 covering functional fit, Part 11/Annex 11, security, performance, and data integrity
• Orchestrate UAT, validation documentation, release cutovers, and hypercare
• Ensure audit readiness and support inspections
• Represent shop-floor users and site leadership in product decisions
• Drive decisions on recipe design, exception handling, review-by-exception, equipment states, and maintenance windows
• Direct vendor teams and statements of work; track delivery performance
• Manage small to moderate product budgets and business cases
• Quantify value realization against committed outcomes
• Define, track, and publish KPIs including lead time, yield, RFT, and downtime
• Drive root-cause analysis and prevention
• Standardize recipes and 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 and IT
• Perform other duties as assigned

Requirements

• 12+ years of experience in biopharma manufacturing or industrial technology
• 3+ years as a Product Owner, Product Manager, or Business Analyst delivering GxP shop-floor systems
• Deep understanding of biologics drug substance operations, including seed train, bioreactors, harvest/clarification, chromatography, UF/DF, buffer/media preparation, and CIP/SIP
• Experience with equipment readiness and maintenance on the shop floor
• Leadership of multi-site MES/eBR initiatives using 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 or Azure DevOps
• Excellent prioritization and stakeholder communication
• Hands-on MES/eBR experience in regulated environments
• Any combination of education and experience providing an equivalent background to deliver role expectations
• Preferred: experience harmonizing multi-platform MES estates and establishing network standards
• Preferred: exposure to e-logbooks/downtime tracking, site automation standards, OT networks, and cybersecurity constraints

Core Competencies

Demonstrates expertise in product strategy and roadmap development for manufacturing execution, with a strong focus on GxP compliance, Agile methodologies, and stakeholder communication. Proficient in managing MES/eBR systems and ensuring audit readiness in biopharma manufacturing environments.

Highest-signal resume keywords

• Product Strategy Development
• GxP Compliance
• Agile Methodologies
• MES/eBR Systems Management
• Stakeholder Communication

Hard Skills

• Biopharma Manufacturing
• Recipe Orchestration
• Root-Cause Analysis
• KPI Tracking
• Data Integrity
• CGMP Controls
• Equipment Readiness
• User Acceptance Testing
• Validation Documentation
• Budget Management

Soft Skills

• Prioritization
• Leadership
• Communication

Industry Keywords

• Biologics Drug Substance Operations
• ISA-88/95
• Shop-Floor Systems
• Cybersecurity Controls
• OT Networks

Tools & Technologies

• Jira
• Azure DevOps
• Syncade
• PAS-X
• DeltaV