Facilities Director

Neurona Therapeutics • South San Francisco, CA

12d • Onsite

About The Position

Neurona Therapeutics is seeking a strategic and hands-on Director of Facilities to lead site infrastructure supporting GMP cell therapy manufacturing and associated operations. The ideal candidate is a technically strong, collaborative leader who thrives in a fast-paced, highly regulated environment and is passionate about building and maintaining infrastructure that supports life-changing therapies. The Director of Facilities will provide end-to-end leadership of facilities, utilities, and infrastructure, ensuring systems are reliable, compliant, and scalable to support clinical development and commercialization. This role is critical to ensuring our facilities are inspection-ready and enabling uninterrupted manufacturing operations. scalable, and capable of supporting clinical-stage manufacturing and future commercialization. The Director will operate at the intersection of Facilities, Manufacturing, and Quality, driving operational excellence while ensuring full regulatory compliance with GxP requirements. The successful candidate will combine deep technical expertise in GMP facilities and utilities with strong leadership, project execution, and cross-functional collaboration capabilities.

Requirements

• Bachelor’s degree in engineering, Facilities Management, or related technical field (advanced degree preferred).
• 8–12+ years of progressive facilities leadership experience in biotech, biopharma, or cell/gene therapy manufacturing.
• Strong hands-on knowledge of GMP cleanroom environments and regulated manufacturing infrastructure.
• Demonstrated experience supporting regulatory inspections and audits.
• Experience leading capital projects, renovations, or facility expansions.
• Strong knowledge of HVAC systems supporting cleanroom classifications and controlled environments.
• Proven ability to manage vendors and technical service providers.
• Excellent organizational, problem-solving, and communication skills.
• Ability to work on-site and wear appropriate personal protective equipment as required.

Nice To Haves

• Experience in cell therapy, gene therapy, or other advanced therapy medicinal products (ATMPs).
• Experience supporting clinical-stage manufacturing.
• Familiarity with single-use systems and aseptic processing environments.
• Experience scaling from clinical to commercial.

Responsibilities

• Provide leadership and oversight for GMP manufacturing suites, cleanrooms, QC laboratories, and site infrastructure.
• Ensure reliable operation of critical utilities, including HVAC, HEPA filtration, clean utilities, compressed gases, backup power, and environmental monitoring systems.
• Establish and maintain robust preventive maintenance, calibration, and asset lifecycle management programs.
• Identify, troubleshoot, and resolve infrastructure-related issues minimizing operational disruption.
• Improve systems and processes related to calibration, preventive maintenance, and work orders.
• Ensure facilities and utilities operate in full compliance with applicable cGMP and global regulatory expectations.
• Partner closely with Quality to manage deviations, change controls, CAPAs, and risk assessments related to facilities and utilities.
• Maintain facilities in a validated state and ensure readiness for inspections at all times.
• Lead facilities-related support during regulatory inspections and internal audits.
• Ensure appropriate documentation practices and adherence to cGMP policies and procedures.
• Lead capital planning and execution for facility expansions, upgrades, and infrastructure improvements.
• Oversee end-to-end project delivery, including design, construction, commissioning, qualification, and validation (CQV).
• Manage external partners including architects, engineers, contractors, commissioning and technical service providers.
• Ensure projects are delivered on schedule, within budget, and in compliance with GMP and operational requirements.
• Develop and manage operating and capital budgets aligned with strategic long-term priorities.
• Manage and optimize relationships with facilities vendors, contractors, engineering firms, and service providers.
• Identify and implement cost efficiencies while maintaining quality, safety, and regulatory compliance.
• Monitor operational performance using defined key performance indicators.
• Serve as a key partner to Manufacturing, Quality, Process Development, Supply Chain, and EHS.
• Provide technical leadership in support of production schedules and clinical program timelines.
• Support business continuity, emergency response, and risk mitigation planning.
• Contribute to cross-functional initiatives and continuous process improvement initiatives.
• Build and develop a high-performing facilities and maintenance organization.
• Establish clear roles, accountability, and performance expectations.
• Foster a culture of safety, compliance, accountability, and operational excellence.
• Mentor team members and support professional development.

What This Job Offers

• Job Type: Full-time
• Career Level: Director