Director, Facility Operations

Role Summary

As the Director, Facility Operations, you’ll lead the strategic and facility operational management of our state-of-the-art clinical manufacturing facility in Redwood City. Your work will be instrumental in operationalizing our GMP facility and scaling critical infrastructure, institutionalizing robust systems, and driving seamless facilities operations across clinical manufacturing, testing labs, and administrative functions.

Responsibilities

• Provide strategic leadership to proactively build and to ensure reliable, compliant, and uninterrupted facility operations.
• Drive efficiency and robustness across all facility functions. Proactively anticipate facility operational and strategic needs and drive actions to fill those gaps.
• Develop and lead enterprise-wide facilities and engineering strategies to support business growth, capacity expansion, and risk mitigation.
• Mentor and manage team members, ensuring alignment of day-to-day operations with broader organizational objectives.
• Champion a proactive safety culture. Oversee EH&S programs and ensure compliance with internal policies and external regulations.
• Provide leadership to ensure timely execution and resolution of Deviations, CAPAs, Change Controls, and Risk Assessments.

Qualifications

• Bachelor’s degree in chemical, bioengineering, mechanical or electrical engineering, or a related field (or equivalent combination of education and experience).
• 10+ years of facilities and engineering experience in the biotechnology or pharmaceutical industry, including people leadership experience.
• Advanced knowledge of facilities systems and strong knowledge/ understanding of FDA regulations (GMPs) and industry standards.
• Solid knowledge of cGMP Quality systems (change management, deviation management and validation).
• Ability to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment.
• Excellent leadership, communication skills and ability to influence across multiple functions to get the job done.
• Strong problem solving and critical thinking skills to drive change and foster flexibility, innovation, and accountability.

Skills

• Strategic planning and operational excellence
• Facilities management including infrastructure, utilities, space planning
• Vendor management and budget oversight
• Regulatory compliance and quality systems (GMP/cGMP)
• Leadership and cross-functional collaboration
• Risk assessment and change control