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.
To establish and manage the Manufacturing function at Neurogene, including all aspects of planning and execution of GMP vector manufacturing. This role will ensure 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 manufacturing staff at Neurogene GMP manufacturing facility.
- Play a key role in start-up and qualification (validation) of new facility and equipment installations and modifications.
- Work with Quality Assurance to achieve and maintain GMP readiness and compliance in manufacturing.
- Drive tech transfer of developed processes from Process Development to GMP.
- Provide GMP Manufacturing 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 and evaluate new equipment or methods to support continuous process improvements.
- Investigate all process related deviations and non-conforming results.
- Write, review, and approve Standard Operating Procedures, Batch Records, Work Instructions, and other quality documentation.
- Ensure 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%
- 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
- Bachelor’s Degree in Biology or Related Field
- 7 years minimum experience managing a GMP manufacturing operation and 4 years minimum supervisory experience; experience in gene therapy manufacturing a plus
- Working knowledge of cGMPs related to Biologics manufacturing
- Able to interpret and apply GMP and regulatory knowledge in routine and non-routine cases.
- Understanding of the principles of biologics manufacturing.
- Experience with all aspects of cell culture methods and techniques including large-scale culture.
- Experience with large-scale purification operations.
- Understanding of the operating principles for aseptic manufacturing.
- 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.