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
The applicant will be an experienced and highly motivated Analytical Method Validation Analyst to support the development, qualification, validation, and implementation of robust analytical methods for our products. This role will play a critical part in supporting the development pipeline and ensuring compliance with all regulatory requirements.

Accountabilities and Responsibilities

• Perform the qualification and validation of analytical methods used for the characterization, potency, and purity testing of gene therapy products.
• Operate and maintain QC Lab instrumentation
• Author, review, and approve analytical method validation protocols, reports, and other validation documents. This includes interpretation of data to conclude acceptability of analytical methods.
• Support the transfer and qualification of analytical methods between different laboratories.
• Investigate and troubleshoot analytical method deviations and out-of specification (OOS) results and ensure any resulting CAPAs are addressed appropriately.
• Interface with other departments (e.g., Manufacturing, Analytical Development, Regulatory Affairs) to ensure alignment and support for analytical method development and validation activities.
• Stay current with the latest advancements in analytical methods and regulatory guidance for gene therapy products.
• Perform other duties as assigned.

Essential Details

Work Schedule

• Full-time; day shift. May require weekend work to support validation activities.

Travel

• N/A

Safety

• Complies with all pertinent safety policies, rules and regulations.

Quality Responsibility

• Maintenance of quality systems and GxP compliance for the business by ensuring that all team members comply with processes, procedures and instructions for all activities in which the team participates.

Scope

• Work on problems of moderate scope. Exercises judgement within defined procedures and policies in selecting methods and techniques in obtaining solutions and in determining appropriate action. Interprets results in comparison to established specifications.

Minimum Requirements

Education

• Bachelor’s degree in life sciences (Chemistry, Biology, Microbiology, Biochemistry), pharmacy or related engineering field

Experience

• 2+ years of extensive experience in an analytical testing role within the pharmaceutical/biotechnology industry, preferred

Knowledge & Skills

• Working knowledge of CGMP requirements for biologics manufacturing.
• Understanding of typical analytical instrumentation.
• Experience with multiple assay types; HPLC, flow cytometer, PCR, ELISA, etc., preferred
• Proficiency in Microsoft Office Suite and laboratory informatics systems (LIMS) is a plus.
• Working knowledge of requirements for aseptic manufacturing.
• Good Aseptic technique
• Excellent communication, interpersonal, and organizational skills.
• Ability to work independently and as part of a team in a fast-paced environment.
• 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.

Working Environment

• Majority of the work is performed in a laboratory environment; work may involve common hazards found in a lab environment. In some areas, owning may be required.

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.