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
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What We Do
Cellares is revolutionizing cell therapy manufacturing. We are developing a one-of-a-kind solution, The Cell Shuttle, to overcome the challenges associated with manufacturing so these life-saving therapies are affordable and widely available to patients who can benefit. The clinical impact of cell therapy in treating cancer has been proven, but this therapeutic approach has several limitations, especially in manufacturing, leaving extremely sick patients waiting for treatment and desperate for hope. Since cell therapy is currently produced for a single patient at a time, it is expensive to manufacture, requiring significant time and resources, and is difficult to scale. Preclinical and clinical scientists, as well as commercial cell therapy manufacturers also lack the options to fully automate their manufacturing process quickly, safely, cost-effectively and at the scale they need. The Cell Shuttle is an automated and closed end-to-end manufacturing solution that is flexible and scalable, enabling customers to run exact processes specified for their cell therapy. Compared with the current manual manufacturing processes for cell therapy, the Cell Shuttle’s next-generation automated manufacturing solution has 10 times the scalability (meaning 10 times more patient doses can be produced simultaneously), enables a three-fold reduction in process failure rates and will reduce the per-patient manufacturing cost by up to 70 percent for most processes.
