Senior IT Lab Specialist

We are seeking a Senior IT Lab Specialist to oversee IT operations supporting the GMP-regulated laboratory environment. This role ensures that all laboratory computer systems, connected instruments, and supporting infrastructure operate reliably, securely, and in compliance with quality, security, and compliance requirements. The specialist collaborates with Laboratory, Quality, and IT teams to handle equipment setup, qualification, backup and restore procedures, and periodic reviews. 

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.

• Provide day-to-day IT support for laboratory instruments, applications, and data systems within a GMP Lab environment
• Troubleshoot and resolve hardware, software, and connectivity issues on lab equipment (Cell Counters, Flow Cytometers, LIMS, PCR, Microbial detection system, etc.)
• Coordinate with instrument and software vendors for maintenance, service requests, and technical escalations
• Manage system backups, data integrity checks, and restore testing per company policies and regulatory requirements
• Maintain user accounts, access controls, and security permissions following defined procedures and segregation of duties
• Act as document owner for IT-related GMP procedures (system administration, backup/restoration, user management, etc.)
• Support validation and qualification activities for lab systems (IQ/OQ/PQ) in collaboration with QA and vendors
• Ensure compliance with 21 CFR Part 11, EU Annex 11, and internal computer system validation policies
• Manage and execute change control activities, including impact assessments, risk evaluations, and approval documentation prior to implementing software patches, configuration changes, or upgrades
• Support periodic review of computerized systems, including patching, lifecycle management, and audit trail review
• Assist in laboratory system upgrades, migrations, and integrations with enterprise applications (e.g., LIMS, ELN)
• Participate in internal and external audits as an SME for laboratory IT systems and infrastructure
• Provide training and guidance to lab users on IT procedures, data handling, and security requirements
• Provide backup support to cross-functional IT teams to ensure continuity of operations and timely resolution of technical issues across laboratory and business systems

• Bachelor’s degree in Information Technology, Computer Science, or related field
• 5-7 years of IT experience in a GMP, GLP, or regulated manufacturing environment
• Solid understanding of laboratory instruments and data systems (LIMS, Cellaca devices, PCR etc.)
• Experience with Windows-based systems, backup technologies, and network configurations
• Familiarity with data integrity standards and GxP documentation practices
• Knowledge of cybersecurity controls in regulated environments
• Working knowledge of validation lifecycle (CSV) and system risk assessments

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.

Salary : $90,000 - $210,000