Director, GMP Systems

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

Additional Information

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. 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.

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