Quality Assurance Specialist - Neurogene Inc.

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.

About the Role

Reporting to the Manager, Quality Assurance, this position will assist in ensuring GxP compliance and quality oversight for Neurogene’s manufacturing operations. This role will collaborate across the company and support the filing of multiple investigational new drug applications and be part of the transformative shift the company is making as we move from the pre-clinical stage to IND enabling studies and to accelerated clinical development. The selected individual will be a team player in a small company environment in this highly cross-functional role.

Responsibilities

• Review and approval of Quality System and cGMP documents including, but not limited to, SOPs, Batch records, protocols and specifications.
• Review and approval of change controls, non-conformances, OOS, deviations, complaints and related items; ensure investigations are thoroughly investigated and resolved.
• QA review of manufacturing and QC related records, resolution of all related issues and QA disposition of product batches.
• Provide on the floor support during ongoing product manufacturing and testing.
• QA review and disposition of raw materials, buffers, labels, and other components.
• QA review of initial qualification, validations and re-validations for facilities, equipment and processes.
• QA oversight and review of QC qualifications and validations.
• Responsible for generation, inspection and release of labels.
• Provide support and QA oversight of drug product shipments to clinical sites.
• Responsible for maintaining the company’s controlled documents in accordance with GxP requirements.
• Ensures escalation of quality issues to management as appropriate.
• Assists in identifying and implementing process improvement opportunities to existing systems.
• Work closely with cross functional teams to ensure all work is completed to high quality in a timely and scientifically rigorous manner.
• Other duties as required.

Qualifications

• Bachelor’s degree in life sciences (Chemistry, Biology, Microbiology, Biochemistry), pharmacy or related engineering field
• At least 3-5 years of relevant experience in the biotech/pharmaceutical industry
• GMP and/or Quality certifications a plus
• Working knowledge of cGMP requirements for biologics manufacturing. Working knowledge of requirements for aseptic manufacturing. Basic knowledge of cell biology, cell culture.
• Ability to work collaboratively in matrix organizations and team.
• Ability to interpret cGMP requirements.
• Must have strong organizational skills and be able to manage and prioritize multiple projects or assignments at one time, including the ability to follow assignments through to completion and meet deadlines.
• Excellent communication (verbal and written) skills required.
• Problem solving skills and ability to make quality decisions based on technical facts and sound risk assessments is required.
• 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.