Sr Director, MES

Sr. Director, Manufacturing Execution System (MES)                                                                              (Hybrid in South San Francisco)

Job Description

We are seeking an experienced and highly motivated Manufacturing Execution System (MES) Director 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.

Key Responsibilities

• 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 (EBR) 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 training programs, and adherence to change control procedures for custom software releases.

Qualifications

• Bachelor's degree in Computer Science, Software Engineering, Electrical Engineering, or a related technical field. Master's degree preferred.
• 12+ years of progressive experience in software development and technical leadership, with at least 7 years specifically focused on designing, developing, implementing, and managing complex enterprise software solutions, preferably in a manufacturing or industrial automation context.
• Proven leadership experience, with at least 5 years managing and developing a team of software developers and technical professionals.
• Minimum of 5 years of direct experience with MES concepts and their application in a GxP-regulated biopharmaceutical manufacturing environment, with a strong emphasis on custom software development.
• Demonstrated expertise in software architecture, design patterns, and full-stack development.
• Proficiency in one or more relevant programming languages (e.g., C#, Java, Python, .NET, JavaScript frameworks like React/Angular/Vue) and database technologies (e.g., SQL Server, Oracle, PostgreSQL).
• Extensive knowledge of GxP regulations (especially cGMP), FDA 21 CFR Part 11, and Eudralex Annex 11, with practical experience applying them to custom software development and validation.
• Strong understanding of biotechnological and biopharmaceutical manufacturing processes (e.g., liquid handling, molecular biology protocols, cell culture, fermentation, purification, aseptic filling, media/buffer prep, etc.) and associated automation/control systems (SCADA, DCS, PLC, HMI) from a software integration perspective.
• Expertise in computer system validation (CSV) and GxP documentation practices, particularly for custom-built systems.
• Experience with system integration (e.g., ERP, LIMS, QMS) using APIs, web services, or other integration technologies.
• Excellent project management skills, with a track record of successfully delivering complex, validated software development projects on time and within budget.
• Strong analytical, problem-solving, and decision-making abilities, with a keen eye for detail in a regulated context.
• Exceptional communication, interpersonal, and presentation skills, with the ability to influence stakeholders at all levels and effectively communicate complex technical and regulatory concepts.
• Ability to travel as required to support global biomanufacturing sites.

Preferred Qualifications

• Experience with specific biopharmaceutical manufacturing processes or modalities (e.g., cell and gene therapy, mAbs, vaccines).
• Open to experience from other industries such as semiconductor. 
• Familiarity with Industry 4.0 concepts, IoT, and advanced manufacturing technologies in a biotech context, with an understanding of how to integrate them into a custom MES.
• Certifications in project management (PMP), Agile methodologies, or relevant software architecture certifications.
• Experience with cloud platforms (e.g., AWS, Azure, GCP) and DevOps practices.
• Direct experience participating in regulatory audits (e.g., FDA inspections) specifically related to custom software and CSV.
• Experience with data analytics tools and methodologies for process monitoring and quality control in biotech, including building custom reporting dashboards.

Twist Bioscience synthesizes genes from scratch, known as “writing” DNA. Just as children learn to both read and write, the next phase of development for the genomics revolution is the ability to write DNA.

At Twist Bioscience, we work in service of people who are changing the world for the better. In fields such as health care, agriculture, industrial chemicals and data storage, our unique silicon-based DNA Synthesis Platform provides precision at a scale that is otherwise unavailable to our customers.

Twist Bioscience Corporation is an Equal Opportunity Employer. Twist Bioscience Corporation provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, genetic characteristics, or any other category protected by law.