Director, GMP Systems

We are seeking a Director, GMP Systems, who will be a hands-on technology and operations leader responsible for stabilizing, scaling, and continuously improving Cellares’ GMP-critical digital backbone as the company transitions from clinical manufacturing to repeatable, audit-ready, pre-commercial operations.

This is a player-coach role. The Director is expected to operate at both strategic and execution levels driving solution decisions, resolving cross-system issues, guiding configuration and data decisions, and directly intervening when necessary to stabilize critical initiatives. The role acts as a bridge between business execution and system delivery, bringing structure, governance, and clarity without slowing innovation.

Candidates should enjoy working in a fast-paced, mission-driven environment, and be prepared to tackle a broad selection of challenges as the company grows.

Responsibilities Operational ownership and execution oversight for business-critical and GMP-impacting systems such as: ERP, Manufacturing Execution & Automation Interfaces, Quality Management Systems (QMS), PLM, Integration & Workflow Platforms, Data & Analytics

Define and execute the GMP systems strategy aligned with manufacturing scale and commercial readiness

Act as the primary systems partner to Manufacturing, Quality, Supply Chain, Engineering, and Finance leadership

Translate evolving operational needs into practical, compliant system solutions

Ensure systems support operational execution, compliance, and unit economics

Ensure manufacturing execution data, inventory, and quality events flow accurately across systems

Enable reliable WIP visibility, inventory valuation, and cost capture early to avoid pre-commercial rework

Support manufacturing readiness without over-engineering controls prematurely

Partner closely with the Integration Architecture & Data Foundation teams to ensure alignment with enterprise architecture and long-term data strategy.

Provide business and GMP requirements for integrations across ERP, MES, QMS, and automation platforms.

Ensure data integrity, traceability, and auditability across manufacturing, quality, and finance processes

Drive root cause resolution for cross-system issues (data, integration, configuration, or process)

Establish operational discipline for transports, releases, documentation, and validation support

Improve business confidence that GMP systems are stable, predictable, and audit-ready

Provide hands-on leadership to drive execution of critical GMP system initiatives

Establish clear priorities, milestones, and operational accountability for internal teams and vendors

Provide day-to-day direction to system integrators and support partners

Partner with IT leadership and Procurement on vendor strategy and performance management

Actively intervene to stabilize, course-correct, or accelerate initiatives as business priorities evolve

Introduce lightweight governance, release discipline, and decision clarity

Improve confidence from QA, Manufacturing, and leadership that systems “just work”

Position IT and systems as business enablers rather than bottlenecks

Requirements Bachelor's in Industrial Engineering, Computer Science, or related field

12–15+ years leading enterprise and manufacturing systems in regulated product companies

Deep experience across ERP, MES, QMS, LIMS and manufacturing data flows

Proven ability to stabilize and scale underperforming systems

Strong partnership with Manufacturing, Quality, Supply Chain, and Finance leaders

Hands-on leadership style, strategic but deeply execution-oriented and comfortable working directly with configurations, data issues, and operational problem resolution

Experience in highly regulated manufacturing (biotech, medical devices, pharmaceutical, aerospace, or similar)

Experience building systems before commercial scale

Track record of translating complex operations into simple, scalable system designs

Comfort operating in fast-growth environments with ambiguity and evolving requirements

Excellent organizational and communication skills

Self-awareness, integrity, authenticity, and a growth mindset

This is Cellares

Cellares is the first Integrated Development and Manufacturing Organization (IDMO) and takes an Industry 4.0 approach to mass manufacturing the living drugs of the 21st century. The company is both developing and operating integrated technologies for cell therapy manufacturing to accelerate access to life-saving cell therapies. The company’s Cell Shuttle integrates all the technologies required for the entire manufacturing process in a flexible and high-throughput platform that delivers true walk-away, end-to-end automation. Cell Shuttles will be deployed in Cellares’ Smart Factories around the world to meet total patient demand for cell therapies at global scale. Partnering with Cellares enables academics, biotechs, and pharma companies to accelerate drug development and scale out manufacturing, lower process failure rates, lower manufacturing costs, and meet global patient demand. The company is headquartered in South San Francisco, California with its commercial-scale IDMO Smart Factory in Bridgewater, New Jersey. The company is backed by world-class investors and has raised over $355 million in financing.

Leveling will be based on overall experience, education, and demonstration of knowledge throughout the interview process.