About the job

Company Background
At Neurogene, we focus on bringing life-changing genetic medicines to patients and families affected by rare, devastating neurological diseases. Our clinical-stage company is developing NGN-401 for the treatment of Rett syndrome and NGN-101 for the treatment of CLN5 Batten disease. We are using our proprietary EXACT transgene regulation technology and internal expertise to develop novel approaches and treatments to address the limitations of conventional gene therapy in central nervous system disorders. Our wholly owned and fully operational GMP-capable manufacturing facility supports vector production from research through clinical grade and is designed for commercial-grade production. In addition, Neurogene is now trading on the NASDAQ Global Market. This transformative work is driven by our highly collaborative people and comes together to bring us closer to achieving our mission of turning devastating diseases into treatable conditions, to improve the lives of patients and their families. As an employee of Neurogene, you will be part of building a culture that honors patient and caregiver mindsets and nurtures innovation, creative problem solving and a strong sense of purpose.

Position Overview
As the Director of Facilities at Neurogene in Houston TX, you will be responsible for overseeing the maintenance and operation of the physical infrastructure and systems of the facility. This includes managing building maintenance, security, utilities, and equipment to ensure a safe and efficient work environment for our researchers and staff. This role will help maintain an uninterrupted supply of clinical materials by ensuring facilities and equipment are kept in a GMP compliant, calibrated and operational state.

Accountabilities and Responsibilities

• Manage the Facilities and Engineering Department personnel.
• Develop and manage the facility budget and participate in budget meetings as it relates to facility operation, maintenance activities, and capital expenses.
• Oversee procurement of necessary supplies and services including negotiation of service contracts.
• Prepare detailed project proposals and justifications, considering cost-benefit analyses for facility upgrades.
• Prioritize, plan, coordinate and schedule calibration, maintenance, and other work for the facility, with internal and external service providers, ensuring adherence to Safety and Quality best practices.
• Manage the operation of utilities such as HVAC, plumbing and electrical systems and of the facility, including pest control program. Conduct and document regular inspections and maintenance of facilities and equipment.
• Develop and maintain GMP policies and procedures to ensure compliance of facility operations with regulatory requirements and industry standards.
• Work cross-functionally with Quality Assurance to ensure GMP compliance and audit readiness of the facility at all times. Act as the primary point of contact during regulatory inspections and audits related to facility operation.
• Oversee on-time completion of quality items related to facility operations including but not limited to; change controls, deviations, and CAPAs.
• Investigate equipment and instrument failures and lead the root cause analysis in support of investigations.
• Oversee installation, operation, maintenance, and repairs to ensure that equipment and instrumentation are installed and functioning according to specifications. Manage calibration, maintenance, and work order activities in the CMMS system to ensure that all system data are updated, accurate, and compliant following approved procedures.
• Oversee proper documentation of alarm responses to facility and equipment.
• Work closely with Manufacturing, Process Development and Quality Control to address facility needs.
• Developing and implementing emergency preparedness plans and procedures including risk mitigations.
• Support continuous operation of the facility during unexpected weather events and power outages.
• Manage future facility expansion projects.

Essential Details

Work Schedule

• Day shift

Travel

• <10%

Safety

• Is knowledgeable and complies with all pertinent safety policies, rules and regulations.
• Ensure that all team members comply with safety rules and regulations.

Quality Responsibility

• Maintenance of quality systems and CGMP compliance for the business by ensuring that all team members comply with processes, procedures and instructions for all activities in which the team participates.
• All personnel are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, product defects and related actions (e.g. quality related complaints, recalls, regulatory actions, etc.).
• Maintain the facility in a state of audit readiness at all times.

Job Scope

• Works on issues of diverse scope where analysis of situation or data requires a review and evaluation of identifiable factors. Exercises judgment within defined procedures and policies in selecting methods and techniques in obtaining solutions and in determining appropriate action. Ensures schedules and performance requirements are met.

Leadership Responsibility

• Provides appropriate coaching and performance feedback to all direct reports and assures that all team members are being developed.

Minimum Requirements

Education

• Bachelor’s Degree required. Mechanical engineering, chemical engineering, biomedical or related science field desired.

Experience

• Facilities and Engineering experience required. 10+ years of relevant experience in a regulated industry (preferably FDA regulated biotech/ pharmaceutical). Additional years of relevant experience may also qualify.
• Experience with vendor management required.
• Experience with forecasting and budgeting.
• Experience with planning, implementing, and maintaining the infrastructure and equipment of buildings and facilities.
• Experience using CMMS software, preferably Blue Mountain RAM.
• Experience ensuring GMP compliance.
• Experience with IT network design is a plus.

Licenses or Certifications

• N/A

Knowledge, Skills and Attributes

• Understanding of facility design requirements and operating principles for aseptic manufacturing.
• Knowledge of industry and GMP regulations and quality assurance policies.
• Must have strong communication skills, both written and oral.
• Demonstrate skills in problem-solving and providing solutions.
• Interact effectively with staff members from multiple levels and departments.
• Must have strong organizational skills and be able to manage and prioritize multiple projects or assignments at one time, including ability to follow assignments through to completion and meet deadlines.
• Able to clearly communicate observations with management from other departments.
• Continuous strong focus on meeting or exceeding expectations in executing
  deliverables, performance and results.
• Ability to track and measure performance against defined metrics.
• Self-starter with high degree of energy, independence, initiative, and self-motivation, as illustrated by the ability to instill a sense of pace and urgency into the team.
• Someone who moves fast and decisively in a balanced manner, with a passion for the growing company.
• Passionate, collaborative, creative, willing to take prudent risks, and motivated by the creation of a company focused on transformative treatments for patients and their families.

Working Environment

• A majority of the work is done in a private office, warehouse or manufacturing environment. Work may involve high energy hazards, such as steam, high pressure gases, flammable materials, high temperature liquids and high voltages, cryogenic operations, loud machinery and chemical hazards such as strong acids and bases.

This job description has been developed based upon the expected and current duties, responsibilities and requirements for the position.
Because job requirements evolve with the changing needs of Neurogene’s business, this description is subject to change and may be modified at any time, whether formally or informally.