Lead and stabilize GMP-critical enterprise and manufacturing systems (ERP, MES, QMS, PLM, LIMS), ensure data integrity and traceability, drive integrations, governance, and validation, partner with Manufacturing/Quality/Finance, and provide hands-on leadership to make systems audit-ready and scalable for commercial manufacturing.
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.
Top Skills
Automation Interfaces
Data & Analytics
Erp
Integration Platforms
Lims
Manufacturing Execution & Automation Interfaces
Mes
Plm
Qms
Workflow Platforms
Cellares South San Francisco, California, USA Office
345 Allerton Ave, South San Francisco, CA, United States, 94080
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