Description
Position Overview - Houston, TX (Onsite)
Neurogene is seeking an established leader for our Houston based Analytical development team. The successful candidate will support and guide the Analytical development team on day-to-day activities as well Phase 2/3 or registration-stage AAV gene therapy programs.
Requirements
Accountabilities and Responsibilities
• Provide analytical development leadership for late stage (Phase 2/3 and registration stage) AAV gene therapy programs, ensuring readiness for pivotal trials, licensure, and commercialization.
• Establish and maintain analytical control strategies, including specification setting, method lifecycle management, and continued process verification.
• Lead comparability strategy development and execution to support manufacturing changes, scale up, technology transfer, and site changes.
• Serve as the primary analytical development partner to Regulatory Affairs, supporting IND amendments, BLA submissions, health authority interactions, and regulatory inspections
• Oversee assay validation, reference standard qualification, and transfer of analytical methods into commercial Quality Control laboratories, ensuring inspection ready execution.
• Establish analytical methods to identify, measure, characterize, and track critical product quality attributes across the pipeline.
• Develop and implement cGMP-suitable analytical methods for product characterization, in-process monitoring, development, and stability testing.
• Manage technology transfers from academic institutions and CROs as new programs come online, followed by transfer to Quality Control.
• Plan, resource, and manage all analytical development activities in collaboration with Process Development.
• Serve as an analytical development SME to interact with commercial development and other stakeholders; communicate direction and progress effectively.
• Hire, train, supervise, and develop direct reports; encourage continuing education and professional development.
• Manage shifting priorities and deliver results in a fast-paced, dynamic environment requiring strong cross-functional communication.
Minimum Requirements
EducationPh.D. in Biochemistry, Cell Biology, or related scientific discipline.
Experience Minimum of 10 years of relevant experience with at least 5 years of management experience, preferably in biotechnology or gene therapy development.
Knowledge, Skills and Attributes
Strong working knowledge of global cGMP regulations and regulatory expectations for biologics and gene therapy. Demonstrated expertise in analytical method development including but not limited to potency assays. Strong problem-solving ability, communication skills, and leadership capabilities and team leading.
• Proven experience establishing comparability strategies and analytical control programs to support process changes, scale-up, and PPQ.
• Direct experience authoring, reviewing, and defending analytical sections of IND, BLA, and regulatory briefing documents.
• Strong understanding of global regulatory expectations for gene therapy analytics, including FDA, EMA, and CBER interactions.
. Deep expertise in AAV capsid characterization, genome integrity, potency assays, empty/full determination, and impurity profiling.
• Experience leading assay validation, lifecycle management, reference standard qualification, and tech transfer into commercial QC.
• Ability to build and mentor high-performing analytical teams in a matrixed, late-stage development environment with tight timelines.
Work Environment Primarily onsite work in a demanding and fast-paced laboratory and manufacturing environment.
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.
