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 Manager to lead our team in ensuring 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

• Lead and manage a team of scientists responsible for the qualification and validation of analytical methods used for the characterization, potency, and purity testing of gene therapy products.
• Develop and implement a comprehensive analytical method validation program in accordance with CGMP, ICH guidelines, and other regulatory requirements.
• Develop analytical method validation plan for current programs and responsible for coordination, planning and communication on execution of deliverables.
• Author, review, and approve analytical method validation protocols, reports, and other validation documents. This includes interpretation of data to conclude acceptability of analytical methods.
• Conduct gap analyses to identify and address deficiencies in existing analytical methods.
• Train and mentor scientists on analytical method validation principles and best practices.
• Oversee the transfer and qualification of analytical methods between different laboratories. Plan and manage validation activities with contract laboratories.
• Manage risk assessments for analytical methods and ensure appropriate controls are in place.
• 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.
• Support internal and regulatory authority audits.
• Perform other duties as assigned.

Essential Details

Work Schedule

• Full-time; days. The role will mostly involve standard working hours, but flexibility is required to attend meetings and calls. Weekend work possible to support production schedules and/or validation plan deliverables.

Travel

• The role may include travel to meet vendors and attend conferences and meetings.

Safety

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

Quality Responsibility

• Development and 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

• Works on complex problems where analysis of multiple factors and consideration of data must be interpreted for decisions to be made. Must be able to utilize past experience and established industry practices to temper decisions under consideration. Exercises judgment within a broad spectrum of situations which affect product, policy and procedures. Responsible for supervision of team members including but not limited to work distribution, scheduling, training, assistance in solving problems, etc. Includes personnel functions such as salaries, discipline, promotions, timesheets, etc. Also provides guidance and direction over individuals who proceed on their own initiative in compliance with policies, practices and procedures. Acts as supervisor to subordinates to meet schedules and/or resolve technical problems. Develops and administers budgets, schedules and performance requirements.

Leadership Responsibility

• Responsible for leading and developing a group of scientists to support analytical method validation program. The role will involve working closely with the Director, QC as well as operational teams across the company.

Minimum Requirements

Education

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

Experience

• 7+ years of extensive experience in a Quality Control role within the pharmaceutical/biotechnology industry, including experience in validation of analytical methods, with proven management experience.

Knowledge & Skills

• Working knowledge of CGMP requirements for biologics manufacturing.
• Strong understanding of CGMP, ICH guidelines, and other relevant regulatory requirements for analytical methods.
• Strong understand of multiple assay types; HPLC, flow cytometer, PCR, ELISA, etc.
• Proven experience in managing and leading a scientific team.
• Demonstrated experience in problem-solving, critical thinking skills, and troubleshooting analytical methods.
• Proficiency in Microsoft Office Suite and laboratory informatics systems (LIMS) is a plus.
• Working knowledge of requirements for aseptic manufacturing. Basic knowledge of cell biology, cell culture.
• Ability to effectively develop and lead teams and work collaboratively in matrix organizations.
• 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 skill 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.

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.