Manager, Facility Operations

Role Summary

We are seeking a dynamic and highly motivated Manager of Facility Operations to join our rapidly expanding Technical Operations team in Redwood City. At Arcellx, we’re pioneering cell therapy manufacturing, leveraging cutting-edge technology to transform patient lives. As a key player, you’ll enable the launch and operationalization of our state-of-the-art Clinical Manufacturing facility. Your leadership and effort will shape critical capabilities, establish robust systems, and ensure seamless day-to-day support for clinical manufacturing and testing labs.

Responsibilities

• Ensuring Robust Production: Lead cell therapy facility operations support activities to ensure robust and safe production in compliance with cGMP requirements.
• Documentation and Compliance: Develop, review, and approve SOPs, protocols, and documents related to facilities operations, engineering, maintenance, and life cycle management.
• Operations Execution and metrics: Coordinate with manufacturing for execution of discrete patient lots or healthy donor runs to deliver on pipeline/ clinical trial needs. Maintain KPI’s related to facility operations. Operate with Safety first, Quality always mindset.
• Investigations and Change controls: Support Facility related investigations, implement corrective actions, manage change controls, and support gap assessments for tech transfer activities.
• Facility Management: Oversee building systems, utilities, and space planning for manufacturing, and lab areas. Support proposed construction, facility qualification & modification projects as needed.
• Maintenance and Asset Management: Track facilities operations and manage equipment calibration and preventative maintenance.
• Business Continuity: Assist in developing Business Continuity Processes for critical business systems, manufacturing, and lab processes.

Qualifications

• Minimum 8 years of manufacturing and/or facility operations support experience in the biotechnology or pharmaceutical industry. Candidates with more experience may be considered at the senior manager level.
• Strong knowledge/ understanding of FDA regulations (GMPs), industry standards, and cGMP Quality systems.
• Proficiency in Operational Excellence principles/ initiatives to implement continuous improvement in manufacturing is a plus.
• Thrives in a fast-paced, dynamic environment. Can manage shifting priorities to meet critical deadlines while providing clear direction to team members.
• Demonstrates strong collaboration, communication, and problem-solving skills.

Education

• Bachelor’s degree in biological sciences, chemical, bioengineering, mechanical or electrical engineering (or equivalent combination of education and experience).