Director, Facility Operations

Role Summary

Director, Facility Operations — Lead the strategic and facility operational management of a state-of-the-art clinical manufacturing facility, focusing on operationalizing GMP facilities, scaling critical infrastructure, and driving seamless facilities operations across clinical manufacturing, testing labs, and administrative functions.

Responsibilities

• Provide strategic leadership to proactively build and 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.
• Oversee the end-to-end management of GMP and non-GMP facilities, including infrastructure, critical utilities, space planning, interaction with landlord facility team and technical projects.
• Ensure readiness to support dynamic operational needs, including construction and qualification of new or modified spaces.
• Lead strategic vendor management. Negotiate contracts with third-party service providers to secure favorable terms and ensure alignment with budgetary constraints.
• Manage facilities budget ensuring alignment with financial targets. Identify opportunities to streamline vendor operations and reduce costs through process improvements and technology adoption.
• Own and drive long-term asset management strategies, including preventative and predictive maintenance, calibration programs, and lifecycle oversight of all critical infrastructure.

Qualifications

• Bachelor‚Äôs 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

• Strategy development and operational excellence
• Facility life cycle management
• Vendor and contract management
• Budget management and cost optimization
• People leadership and cross-functional collaboration
• Regulatory compliance and quality systems

Education

• As listed in Qualifications

Additional Requirements

• None specified beyond the above qualifications and responsibilities.