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Director of Facilities and Operations

2 months ago

Houston, Texas, United States Neurogene, Inc. Full time
Director of Facilities and Operations

We are seeking a highly skilled and experienced Director of Facilities and Operations to oversee the maintenance and operation of our physical infrastructure and systems in a regulated industry.

About the Role
  • Oversee the maintenance and operation of the physical infrastructure and systems of the facility, including building maintenance, security, utilities, and equipment.
  • Ensure a safe and efficient work environment for our researchers and staff.
  • Maintain an uninterrupted supply of clinical materials by ensuring facilities and equipment are kept in a compliant, calibrated, and operational state.
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 best practices.
  • Manage the operation of utilities such as HVAC, plumbing, and electrical systems and of the facility, including pest control programs.
  • Conduct and document regular inspections and maintenance of facilities and equipment.
  • Develop and maintain policies and procedures to ensure compliance of facility operations with regulatory requirements and industry standards.
  • Work cross-functionally with Quality Assurance to ensure 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.
  • Develop and implement 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.
Qualifications
  • Bachelor's Degree required, Mechanical engineering, chemical engineering, biomedical, or related science field desired.
  • 10+ years of relevant experience in a regulated industry (preferably FDA regulated biotech/pharmaceutical).
  • 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 compliance.
  • Experience with IT network design is a plus.
Preferred Skills
  • Understanding of facility design requirements and operating principles for aseptic manufacturing.
  • Knowledge of industry and regulatory requirements and quality assurance policies.
  • 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.
  • Strong organizational skills and ability to manage and prioritize multiple projects or assignments at one time.
  • 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.
  • 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.