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Manager of Facilities and Engineering
Houston, TX

Background
Neurogene exists to provide medicines to cure or substantially improve the lives of families and people living with neurologic impairment. The day to day difficulty of caring for someone with a devastating neurologic disorder is a heavy burden for families, and we imagine a world where families no longer have to hear the message that their rare disease has no treatment. As an employee of Neurogene, you will be helping to make this dream a reality, and part of a culture of people in a start-up environment on a mission to make the world a better place!

Role Purpose:
To establish and manage the Facilities and Engineering function at Neurogene including all aspects of facility operation, preventive maintenance, repair and calibration. This role will help maintain an uninterrupted supply of clinical materials by ensuring facilities and equipment are kept in a calibrated and operational state.

Primary Accountabilities, Duties, and Responsibilities

  • Manage engineering, maintenance and calibration staff at Neurogene.
  • Provide on-machine expertise to operators and other staff personnel to ensure manufacturing capability and capacity are meeting delivery and performance targets. Support all shifts as required.
  • Work closely with Manufacturing, Process/Analytical Development and Quality Control to resolve issues and improve efficiency of operations.
    Identify, evaluate and procure new equipment/components to support process improvements.
  • Review design drawings.
  • Develop and implement Preventive Maintenance and Calibration procedures for key processes and equipment.
  • Play a key role in start-up and qualification (validation) of new equipment installations and modifications.
  • Work with Quality Assurance to achieve and maintain GMP compliance for the facility, specifically in the area of HVAC and other utilities.
  • Write, review, and approve operations and equipment SOPs and change control documents.
  • Ensure proper documentation is completed to meet quality systems requirements.
  • Participate in facility safety programs.
  • Hire, train, and supervise direct reports, and encourage continuing education and development.

Essential Job Functions

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

Minimum Required Qualifications/Skills

  • Education: Bachelor’s Degree required.
    • Mechanical engineering, chemical engineering, biomedical or related science field desired.
  • Experience
    • Facilities and Engineering experience required. 3-5 years of relevant experience in a regulated industry (preferably FDA regulated biotech/ pharmaceutical). Additional years of relevant experience may also qualify. Vendor management experience desired.
      Experience with IT network design is a plus.
  • Knowledge
    • Must have an introductory knowledge of cGMP requirements.
    • Working knowledge of utility control and building management systems.
  • Skills
    • Able to perform procedures according to written guidelines.
    • Must have strong communication skills, both written and oral.
    • Able to develop new procedures when required.
    • Demonstrate skills in problem-solving and provide 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.
    • Ability to lift 50lbs, assisted.
    • Demonstrated strength as a manager including mentoring and coaching of staff, establishing priorities, and delivering on projects within budget and on time.
  • Working Conditions
    • 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.

Email cover letter and resume to GQRrecruitment@neurogene.com .

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