Facilities Director at Neurona Therapeutics

South San Francisco, California, United States -

Full Time

Start Date

Immediate

Expiry Date

03 Aug, 26

Salary

0.0

Posted On

05 May, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

GMP Facilities Management, HVAC Systems, Cleanroom Operations, Capital Project Management, Regulatory Compliance, CQV, Vendor Management, Budget Management, Asset Lifecycle Management, Environmental Monitoring, GxP Requirements, Risk Assessment, Preventive Maintenance, Cross-functional Leadership, Calibration, Aseptic Processing

Industry

Biotechnology Research

Description

Company Overview: Neurona Therapeutics is a clinical-stage biotechnology company based in South San Francisco focused on the development of neuronal cell-based therapies for intractable neurological diseases. Our mission-driven team is advancing innovative cell therapies to address significant unmet medical needs. Neurona 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. Position Summary: 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. Key Responsibilities: GMP Facilities & Utilities Leadership 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. Regulatory & Quality Compliance * 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. Capital Projects & Site Expansion * 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. Vendor & Budget Management * 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. Cross-Functional Partnership * 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. Team Leadership * 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. Required Qualifications: * 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. Preferred Experience: * 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. This job description is not exhaustive and not intended to cover all activities of the position. Duties, responsibilities and activities may change, or new ones may be assigned at any time with or without notice. Neurona is proud to be an equal opportunity employer and will consider all qualified applicants for employment. Recruitment Fraud Notice We are aware of active recruitment scams using the Neurona name, where individuals pose as our recruiters or post fake remote job openings and make fraudulent job offers online. Please note, that we will never make an offer of employment without conducting multiple rounds of face-to-face interviews using secure video-conferencing technology. Additionally, we will never ask candidates to cash checks or make any payment to be considered for a position. If you believe you have been a victim of a phishing scam, please visit the Cybersecurity & Infrastructure Security Agency (CISA) at https://www.cisa.gov/be-cyber-smart/report-incident to learn how to report it.

Responsibilities

Lead the end-to-end management of facilities, utilities, and infrastructure to support GMP cell therapy manufacturing and clinical development. Oversee capital projects, ensure regulatory compliance for inspections, and manage vendor relationships and budgets.