Senior Director, CMC Technical Lead

Company Background

The mission of Neurogene is to treat devastating neurological diseases to improve the lives of patients and families impacted by these rare diseases. Neurogene is developing novel approaches and treatments to address the limitations of conventional gene therapy in central nervous system disorders. This includes selecting a delivery approach to maximize distribution to target tissues and designing products to maximize potency and purity for an optimized efficacy and safety profile. The Company’s novel and proprietary EXACT transgene regulation platform technology allows for the delivery of therapeutic levels while limiting transgene toxicity associated with conventional gene therapy.

Brief Description

Company Background

The mission of Neurogene is to treat devastating neurological diseases to improve the lives of patients and families impacted by these rare diseases. Neurogene is developing novel approaches and treatments to address the limitations of conventional gene therapy in central nervous system disorders. This includes selecting a delivery approach to maximize distribution to target tissues and designing products to maximize potency and purity for an optimized efficacy and safety profile. The Company’s novel and proprietary EXACT transgene regulation platform technology allows for the delivery of therapeutic levels while limiting transgene toxicity associated with conventional gene therapy.

Neurogene has constructed a state-of-the-art gene therapy manufacturing facility in Houston, Texas. CGMP production of NGN-401 was conducted in this facility and will support pivotal clinical development activities. This transformative work is driven by our highly collaborative people who come together each day to bring us closer to achieving our mission. 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 – Hybrid/Remote w Travel to Houston TX as needed.

The Senior Director, CMC Technical Lead is a senior individual-contributor role responsible for the technical integrity of the drug product and for connecting the technical narrative across Analytical Development, Process Development, MSAT, Quality Control, and Quality Assurance. Reporting to the SVP, Technical Operations, this role owns the integrated control strategy and the technical narrative of Module 3, and is accountable for their scientific defensibility as the lead AAV gene therapy program advances through Process Performance Qualification (PPQ), BLA preparation, and commercial launch.

This position addresses a critical BLA-preparation capability need: translating Neurogene’s deep AAV manufacturing and analytical expertise into a coherent, inspection-ready regulatory story. The role works horizontally across established CMC functions—integrating the technical artifacts that span those functions rather than managing the functions themselves—and chairs the CMC Technical Review Board, the governance forum where cross-functional BLA technical decisions are made and recorded. It partners closely (dotted line) with Regulatory CMC, which retains ownership of filing strategy and health-authority interactions.

Requirements

Accountabilities and Responsibilities

• Own the integrated control strategy — serve as the single technical owner of the end-to-end control-strategy narrative, connecting critical quality attributes (CQAs) to critical process parameters (CPPs), in-process controls, and release and stability specifications, with clearly documented criticality logic for each linkage.
• Integrate the technical story across functions — connect the scientific narrative across Analytical Development, Process Development, MSAT, Quality Control, and Quality Assurance so that Module 3 presents one internally consistent technical argument.
• Craft the BLA / Module 3 technical narrative — author and integrate the technical content and scientific justification for CTD Module 3 sections (e.g., S.2.6, P.2, specification and process-characterization justifications), ensuring the process characterization ? PPQ ? continued process verification (CPV) storyline is coherent and inspection-ready.
• Lead comparability strategy — define and steward the comparability strategy across process changes and PPQ, ensuring technical consistency and regulatory defensibility.
• Ensure criticality and risk-assessment consistency — ensure CQA and CPP risk assessments and rankings are scientifically sound and internally consistent across all functional inputs.
• Chair the CMC Technical Review Board — chair the cross-functional governance body where BLA technical decisions are made and recorded, driving timely, evidence-based resolution of cross-functional technical issues.
• Support BLA authoring and health-authority interactions — partner with Regulatory CMC to translate technical positions into filing-ready content and to prepare responses to health-authority questions and pre-approval inspection queries; serve as a technical subject-matter expert in agency interactions.
• Own reference-standard strategy and specification justification — oversee the technical basis for the reference-standard strategy and the scientific justification of release and stability specifications.
• Bridge process science to commercial readiness — ensure process and analytical understanding developed through characterization and PPQ is carried into the control strategy and lifecycle management (CPV) as the program transitions to commercial supply.
• Serve as senior technical advisor — act as a senior individual-contributor technical authority to the SVP, Technical Operations and the CMC leadership team, leading through defined decision rights rather than direct line management of the contributing functions.
• Uphold Quality and Regulatory independence — integrate the technical narrative while preserving the independence of Quality decisions (batch disposition, deviation classification, GMP approvals) and Regulatory ownership of filing strategy and agency commitments.

Essential Details - Manufacturing ONLY

Work Schedule

Day shift

Travel

<15% (site visits, health-authority meetings, inspections)

Safety

Is knowledgeable of and ensures compliance with all company safety policies; ensures team compliance.

Quality Responsibility

Responsible for supporting cGMP compliance and data integrity across all departments.

Scope Individual contributor

with defined cross-functional technical decision rights across CMC Module 3 functions (Analytical Development, Process Development, MSAT, QC, QA). Accountable for the integrated control strategy and Module 3 technical narrative for the lead commercial AAV program.

Leadership Responsibility

No direct reports. Leads through influence and defined decision rights as Chair of the CMC Technical Review Board; positioned as peer / near-peer to CMC function heads, with escalation and organizational air cover provided by the SVP, Technical Operations.

Minimum Requirements

Education

PhD in a relevant scientific or engineering discipline (e.g., biochemistry, molecular biology, virology, analytical chemistry, chemical / biochemical engineering) or degree with equivalent depth of experience.

Experience

Minimum 10+ years in biologics or advanced-therapy CMC, with demonstrated depth across the CMC stack (analytical development, process development / MSAT, and QC / QA interfaces).

• Direct experience authoring and integrating the technical content of at least one BLA / MAA Module 3 (or equivalent marketing application) for a biologic — AAV gene therapy or comparable modality strongly preferred.
• Hands-on familiarity with AAV manufacturing (BEVS / Sf9 or mammalian) and associated analytical characterization.
• Proven track record defining integrated control strategies (CQA / CPP linkage, comparability, specification justification) and supporting health-authority interactions and pre-approval inspections.
• Experience through PPQ and commercial launch of a biologic / advanced therapy preferred.

Licenses or Certifications

None required. Regulatory or quality certifications (e.g., RAC, ASQ CQE / CQA) are a plus.

Knowledge, Skills And Attributes

• Deep command of ICH quality guidelines (Q5A–Q5E, Q6B, Q8–Q12, Q14) and FDA / EMA expectations for gene therapy CMC.
• Able to hold the full control-strategy logic in view while engaging credibly with analytical chemists, process / bioreactor engineers, and QA / compliance leads.
• Strong scientific writing; constructs clear, evidence-graded technical narratives that explicitly separate supported claims from extrapolation.
• Skilled cross-functional integrator and facilitator; drives decisions and resolves technical disputes without direct authority.
• High scientific rigor, epistemic transparency, and sound judgment on criticality and risk.
• Collaborative, patient-focused mindset aligned with Neurogene’s mission.

Work Environment

Hybrid: combines remote work with regular on-site presence at the Houston, TX gene therapy manufacturing facility to support cross-functional technical work, PPQ execution, and inspection readiness. Demanding, fast-paced environment spanning laboratory, manufacturing, and regulatory activities.

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.