VP, MES

VP, Manufacturing Execution System (MES) (Hybrid in South San Francisco)

We are seeking an experienced and highly motivated Manufacturing Execution System (MES) to lead the strategic development, implementation, and optimization of our custom, in-house developed MES solutions across our biomanufacturing operations. This critical role will drive efficiency, quality, and robust data integrity within a highly automated environment. The effective utilization and continuous enhancement of our proprietary MES technologies will ensure strict adherence to regulatory requirements, optimize complex biological manufacturing processes, and align with our overall manufacturing strategy and business objectives.

The Director will lead a team of MES professionals, primarily software developers, who work in concert with Manufacturing Operations, Quality Assurance, and R&D. The Director will serve as the primary technical and strategic expert for all MES-related initiatives.

• Strategic Leadership & Architecture: Define and execute the long-term architectural roadmap for our in-house MES, ensuring scalability, maintainability, and alignment with biomanufacturing strategy, GxP regulations, industry best practices, and technological advancements in biotechnology.
• Technical Team Management: Lead, mentor, and develop a high-performing team of MES engineers, software developers, analysts, and specialists, fostering a culture of continuous improvement, technical excellence, robust software development practices, and regulatory compliance.
• Software Development & Implementation: Oversee the full Software Development Life Cycle (SDLC) for our custom MES, including detailed requirements gathering, system design, coding standards, development, rigorous testing, validation, deployment, and post-go-live support for new and existing biomanufacturing facilities.
• System Optimization & Support: Drive continuous improvement and feature enhancement of existing MES functionalities, identify opportunities for process automation, electronic batch record optimization, and advanced data utilization. Ensure robust system performance, availability, and audit readiness through proactive monitoring and maintenance.
• Cross-Functional Collaboration: Partner closely with the platform architecture and infrastructure teams, Manufacturing Operations, Quality Assurance, Process Development, and Regulatory Affairs teams to define MES requirements, design seamless integrations with other enterprise systems (e.g., ERP, LIMS, QMS), and ensure compliant data flow across the biomanufacturing ecosystem.
• Data Integrity & Reporting: Architect and ensure the accuracy, integrity, traceability, and security of all manufacturing data within the MES, critical for regulatory submissions and audit trails. Develop and implement robust reporting, analytics, and data visualization capabilities to support operational decision-making and quality reviews.
• Compliance & Validation: Ensure our custom MES solutions comply with GxP regulations (e.g., cGMP, GLP), FDA 21 CFR Part 11, Eudralex Annex 11, and internal quality standards. Oversee and execute comprehensive computer system validation (CSV) activities, including IQ, OQ, PQ protocols and documentation, specifically tailored for custom software.
• Electronic Batch Record (E ) Management: Lead the design, development, and continuous improvement of electronic batch records within the MES, ensuring accurate capture of manufacturing data, deviation management, and electronic signatures.
• Vendor & Internal Resource Management: Manage relationships with any external software development contractors or technology partners, ensuring effective collaboration, adherence to GxP standards, and delivery of services. Optimize the utilization of internal development resources.
• Budget Management: Develop and manage the MES department budget, optimizing resource allocation for both internal development and external services, and demonstrating ROI for MES investments.
• Change Management: Lead change management efforts related to MES development, implementations, and upgrades, ensuring user adoption, effective GxP…