Director, GMP Systems

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
• 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
• 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”

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

Pay

$90,000 - $250,000 a year

Schedule

Not specified

Benefits

• Competitive base salaries
• Highly subsidized Medical, Dental, and Vision Plans
• 401(k) Matching
• Free EV Charging
• Onsite lunches
• Stock options

Qualifications

Cellares’ total compensation package contains competitive base salaries, highly subsidized Medical, Dental, and Vision Plans, 401(k) Matching, Free EV Charging, Onsite lunches, and Stock options. All displayed pay ranges are approximate, negotiable, and location dependent.

Company Information

• The company is the first Integrated Development and Manufacturing Organization (IDMO)
• Takes an Industry 4.0 approach to mass manufacturing the living drugs of the 21st century
• Develops and operates integrated technologies for cell therapy manufacturing to accelerate access to life-saving cell therapies
• Cell Shuttles integrate 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
• Backed by world-class investors and has raised over $355 million in financing
• Headquartered in South San Francisco, California with its commercial-scale IDMO Smart Factory in Bridgewater, New Jersey