Company Background
At Neurogene, we focus on bringing life-changing genetic medicines to patients and families affected by rare, devastating neurological diseases. Our clinical-stage company is developing NGN-401 for the treatment of Rett syndrome and NGN-101 for the treatment of CLN5 Batten disease. We are using our proprietary EXACT transgene regulation technology and internal expertise to develop novel approaches and treatments to address the limitations of conventional gene therapy in central nervous system disorders. Our wholly owned and fully operational GMP-capable manufacturing facility supports vector production from research through clinical grade and is designed for commercial-grade production. In addition, Neurogene is now trading on the NASDAQ Global Market. This transformative work is driven by our highly collaborative people and comes together to bring us closer to achieving our mission of turning devastating diseases into treatable conditions, to improve the lives of patients and their families. 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 role will represent the Manufacturing function for quality workflow and quality-based documentation via a Quality Management System (QMS) and Document Management System (DMS) including items like deviations, investigations, change controls, corrective actions and preventative actions, and effectiveness checks. As needed, this role also may support manufacturing operations.

Accountabilities and Responsibilities

• This role will work within the Manufacturing Department reporting to the Manufacturing Manager.
• Represent manufacturing in managing quality events, change controls, continuous improvements and other quality workflows.
• Investigate manufacturing process and facility related deviations for a cGMP biologics manufacturer.
• Collaborate with Technical Operations departments to identify process improvements in the way of CAPAs.
• Participate in audits as needed.
• Write, review, and approve Standard Operating Procedures, Batch Records, Work Instructions, and other quality documentation.
• Supports Manufacturing cGMP production as needed.

Essential Details

Work Schedule

• This role will be expected to support day shift operations Monday through Friday. Occasional support for off-shift hours as needed (early mornings, late evenings/nights, and weekends).

Travel

• <10%

Safety

• This role should be able to lift 35lbs. This role may work around high energy systems, hazardous chemicals and solutions including corrosives and viral materials.

Quality Responsibility

• Support the manufacturing function cGMP compliance by identifying process improvements for safety, quality, and efficiency of process execution.

Scope

• Works on issues of diverse scope where analysis of situation or data requires a review and evaluation of identifiable factors. Exercises judgement within defined procedures and regulations, selects appropriate methods and techniques in obtaining solutions in determining appropriate actions or resolutions.

Minimum Requirements

Education

• Bachelor’s degree in biology or related field

Experience

• 2+ years in investigation experience in a pharmaceutical/biotech industry setting.
• Experience owning change controls preferred.
• Working in or alongside a cGMP process for 2+ years is required.
• Experience working with Gene Therapies preferred.
• High attention to detail.
• Track record of successfully leading collaborations to an end goal.
• Ability to work within a cleanroom environment as needed.

Licenses or Certifications

• Biotechnology/manufacturing certificate a plus
• Lean Six Sigma certifications a plus

Knowledge, Skills and Attributes

• Ability to track and measure performance against defined metrics, such as on-time delivery of quality workflow closure.
• 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.
• 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.
• High attention to detail.
• Knowledge and ability to interpret and understand regulations related to the manufacturing of biologics.
• Work in a Quality Management System.
• Use Root Cause Analysis tools to identify and select a root cause

Working Environment

• A majority 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.

This job description has been developed based upon the expected and current duties, responsibilities and requirements for the position.
Because job requirements evolve with the changing needs of Neurogene’s business, this description is subject to change and may be modified at any time, whether formally or informally.