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MSAT Engineer
Houston, TX

Company Background

The mission of Neurogene is to treat devastating neurological diseases to improve the lives of patients and families impacted by these rare diseases. Neurogene is developing novel approaches and treatments to address the limitations of conventional gene therapy in central nervous system disorders. This includes selecting a delivery approach to maximize distribution to target tissues and designing products to maximize potency and purity for an optimized efficacy and safety profile. The Company’s novel and proprietary EXACT transgene regulation platform technology allows for the delivery of therapeutic levels while limiting transgene toxicity associated with conventional gene therapy. Neurogene has constructed a state-of-the-art gene therapy manufacturing facility in Houston, Texas. CGMP production of NGN-401 was conducted in this facility and will support pivotal clinical development activities. This transformative work is driven by our highly collaborative people who come together each day to bring us closer to achieving our mission. 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
This position will be part of the Manufacturing Science and Technology (MSAT) function at Neurogene. The role of MSAT Engineer will bring on board diverse experiences in biologics processing and will play a key role in supporting, advancing, and optimizing Viral Vector production processes, with the goal of producing transformative therapies.

 

Accountabilities and Responsibilities

  • Collaborate with cross-functional teams to support process transfers, process scale-up, and implementation of process improvements
  • Participate in developing strategies to ensure process manufacturability and scalability, robust process design, optimization and advancement of viral vector programs to commercial stage
  • Provide technical support for manufacturing process execution, conduct or support deviation investigations, utilize efficiently root cause analysis tools, implement corrective actions and prevention plans, and necessary change controls
  • Conduct process data gathering and data analysis to drive manufacturing process improvements and maximize process consistency and manufacture of product that meets predetermined specifications
  • Author, review and/or revise technical documents such as plans, protocols, summary reports, risk assessments, procedures
  • Knowledge of industry trends and adherence to cGMP practices and regulatory requirements

 

Essential Details

  • Work Schedule
    • Day shift (some off-shift hours: early mornings, late evenings/nights, and weekends if necessary)
  • 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.).
  • Scope
    • Works on problems of moderate scope; exercises judgment within defined procedures and policies in selecting methods and techniques in obtaining solutions and in determining appropriate action.
  • Leadership Responsibility
    • Limited. May provide direction for operational team as related to manufacturing. Ability to serve as project/team lead for internal objectives.

 

Minimum Requirements

  • Education
    • Bachelor’s Degree in a scientific discipline such as Biochemical Engineering, Biomedical Engineering, Biotechnology.
  • Experience
    • Minimum 5 years of relevant experience in MSAT, Process Development or Manufacturing supporting biologics/gene therapy processes
  • Licenses or Certifications
    • Biotechnology certificate(s) are a plus
  • Knowledge & Skills
    • Knowledge of cell culture, filtration, chromatography and tangential flow filtration unit operations; applied knowledge of scale-up principles and strategies
    • Knowledge of cGMP and regulatory requirements for product lifecycle management
    • Problem solving and critical thinking skills
    • High attention to detail
    • Excellent verbal and written communication skills
    • Continuous, strong focus on improvement and execution of deliverables on time and at a high quality
    • Self-starter with high degree of energy, independence, initiative, and self-motivation
    • Flexibility to adapt to changing priorities
    • 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
  • Work Environment
    • Much of the work is done in a private office, warehouse or manufacturing environment. The manufacturing environment is a cleanroom where appropriate gowning is required to be worn. 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.
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