Manufacturing Associate – Neurogene

Company Background

At Neurogene, we are working to provide medicines to improve the lives of neurologically impaired children and their families. We envision a world in which all families have access to genetic medicines, even if the disorder is exceedingly rare. For children, our goal is to enable them to have a healthier future. For families, we want to make their lives better by easing the challenges of caring for someone with a devastating neurological disorder. As an employee of Neurogene, you will be part of a culture helping to make this dream a reality, collaborating with people in a start-up environment, whose mission is to improve the lives of the patients we serve and make the world a better place.

Position Overview

The primary role of the Manufacturing Associate position will be production of gene therapy products at Neurogene’s viral vector manufacturing facility. This position will help maintain an uninterrupted supply of materials for clinical trials.

Accountabilities and Responsibilities

  • Operation of manual, semi-automated and automated equipment in support of routine production of pre-clinical and clinical biopharmaceuticals
  • Large scale cell culture using single-use disposable bioreactor systems
  • Viral vector purification with process scale chromatography equipment
  • Preparation of buffer solutions
  • Staging of equipment and raw materials in production suites
  • Assist in other production related activities such as validation, data collection, inventory management and maintenance of process equipment
  • Perform cleaning of facility and unit process equipment
  • Write and review SOPs and change control documents for manufacturing work areas
  • Ensure proper documentation is completed to meet quality systems requirements
  • Participate in facility safety programs

Essential Details

  • Work Schedule – Day shift, some weekend work may be required
  • Travel <10%
  • Safety
    • Is knowledgeable and complies with all pertinent safety policies, 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
    • N/A

Minimum Requirements

  • Education
    • Bachelor’s Degree in Biology, Biotechnology or related science field preferred
  • Experience
    • Preferred but not required: Industrial experience in the area of biopharmaceutical production in a GMP environment
  • Licenses or Certifications
    • N/A
  • Knowledge
    • Understanding complex process equipment and instrumentation
    • Working knowledge of GMP
  • Skills
    • Good aseptic technique
    • Able to perform procedures according to written guidelines
    • Able to develop or revise procedures when required
    • Good basic computer skills
    • Interact effectively with staff members from multiple levels and departments
    • Ability to lift 50lbs, assisted.
  • Working Conditions
    • A majority of the work is done in a manufacturing clean room environment. Work may involve high energy hazards, such as high-pressure gases, flammable materials, cryogenic operations, and chemical hazards such as strong acids and bases. In some areas, gowning (e.g. coveralls, face mask, shoe covers, hair and beard nets etc.) will be required.

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