Director, MES at Twist Bioscience

South San Francisco, California, United States

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

BiotechnologyIndustries

Requirements

Experienced and highly motivated in Manufacturing Execution System (MES) leadership
Expertise in strategic development, implementation, and optimization of custom, in-house MES solutions for biomanufacturing
Deep knowledge of GxP regulations (e.g., cGMP, GLP), FDA 21 CFR Part 11, Eudralex Annex 11, and computer system validation (CSV) including IQ, OQ, PQ
Strong technical expertise in software development life cycle (SDLC), system architecture, scalability, maintainability, and integrations with enterprise systems (e.g., ERP, LIMS, QMS)
Proven leadership and team management skills for MES engineers, software developers, analysts, and specialists
Ability to drive cross-functional collaboration with Manufacturing Operations, Quality Assurance, Process Development, Regulatory Affairs, platform architecture, and infrastructure teams
Proficiency in data integrity, traceability, security, reporting, analytics, and electronic batch record (EBR) management

Responsibilities

Define and execute the long-term architectural roadmap for in-house MES, ensuring scalability, maintainability, alignment with biomanufacturing strategy, GxP regulations, industry best practices, and biotech advancements
Lead, mentor, and develop a high-performing team of MES professionals, fostering continuous improvement, technical excellence, robust development practices, and regulatory compliance
Oversee the full SDLC for custom MES, including requirements gathering, system design, coding standards, development, testing, validation, deployment, and post-go-live support
Drive continuous improvement, feature enhancements, process automation, EBR optimization, and advanced data utilization; ensure system performance, availability, and audit readiness
Partner with cross-functional teams to define MES requirements, design integrations, and ensure compliant data flow across the biomanufacturing ecosystem
Architect and ensure accuracy, integrity, traceability, and security of manufacturing data; develop reporting, analytics, and data visualization for decision-making and quality reviews
Ensure compliance with GxP regulations and standards; oversee CSV activities, protocols, and documentation for custom software
Lead design, development, and improvement of EBRs within MES, including data capture, deviation management, and electronic signatures
Manage relationships with external vendors/contractors and internal resources, ensuring GxP adherence and effective delivery
Develop and manage budget (inferred from incomplete description)

Skills

Key technologies and capabilities for this role

MESSDLCGxPBiomanufacturingSoftware DevelopmentSystem ArchitectureRegulatory ComplianceValidationDeploymentCoding StandardsTeam Leadership

Questions & Answers

Common questions about this position

What is the work arrangement for this position?

The role is hybrid and based in South San Francisco.

What is the salary for this Director, MES position?

This information is not specified in the job description.

What key skills and experience are required for this role?

The role requires experience in strategic leadership for MES architecture, technical team management of software developers and engineers, overseeing full SDLC including requirements gathering, design, coding, testing, validation, and deployment, plus expertise in GxP regulations, data integrity, and cross-functional collaboration in biomanufacturing.

What team will the Director lead?

The Director will lead a team of MES professionals, primarily software developers, who work with Manufacturing Operations, Quality Assurance, and R&D.

What makes a strong candidate for this Director role?

A strong candidate is an experienced leader in MES for biomanufacturing with expertise in custom software development, GxP compliance, team mentoring, SDLC oversight, and cross-functional collaboration to drive efficiency and data integrity.

Twist Bioscience

Produces synthetic DNA for biotechnology applications

About Twist Bioscience

Twist Bioscience specializes in creating synthetic DNA for applications in biotechnology, pharmaceuticals, and research. Their proprietary platform allows for the quick and accurate production of DNA sequences, providing clients with products like genes, oligo pools, and variant libraries. The company stands out by offering high-quality DNA at competitive prices, making them a valuable partner for academic institutions and pharmaceutical companies. Twist Bioscience aims to support advancements in personalized medicine and biotechnology through their innovative DNA synthesis solutions.

South San Francisco, CaliforniaHeadquarters

2013Year Founded

$236.5MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

1,001-5,000Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Disability Insurance

Life Insurance

401(k) Retirement Plan

Risks

Increased competition from Ginkgo Bioworks may impact Twist's market share.

Dependency on AI technologies could pose integration and operational challenges.

New CIO appointment may lead to transitional challenges in IT strategy and operations.

Differentiation

Twist Bioscience uses a unique silicon-based DNA synthesis platform for precision and scale.

They offer high-quality DNA sequences at competitive prices, attracting diverse clients.

Their proprietary platform provides instant feedback on DNA sequence synthesis feasibility.

Upsides

Growing demand for synthetic DNA in personalized medicine boosts Twist's market potential.

Collaboration with Absci leverages AI to accelerate antibody discovery and drug development.

Synthetic biology market projected to grow at 28.8% CAGR, benefiting Twist's growth.

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