AAV CMC Consultant (Independent Contractor)

Accountabilities

• Assess CMC readiness and define strategy: Conduct a comprehensive CMC gap analysis against the target product profile during the first month, identify technical and regulatory risks, and develop a prioritized plan to address outstanding gaps. Review the CDMO master services agreement and initial process development and manufacturing plans, providing practical recommendations.

• Lead CDMO collaboration and project execution: Establish agendas and lead regular technical working meetings, document decisions and action items, assign owners and deadlines, and follow up on deliverables. Monitor progress, resolve issues, escalate risks when necessary, and maintain momentum against project milestones.

• Guide process and analytical development: Provide expert guidance on upstream and downstream AAV manufacturing processes, analytical development, product characterization, and release strategies. Develop recommendations for a phase-appropriate potency assay strategy and help ensure that manufacturing processes and analytical methods align with program requirements.

• Oversee manufacturing readiness and material delivery: Coordinate with the CDMO to support the successful completion of a non-GMP engineering run within the planned six-month engagement, targeting delivery of material for the GLP toxicology study. Monitor manufacturing timelines, material quality, quantity, and readiness for subsequent development activities.

• Develop regulatory CMC documentation: Draft and substantially contribute to Module 3 content for pre-IND and IND submissions. Prepare CMC briefing materials, identify documentation gaps, and ensure technical information is clear, consistent, and aligned with the program's regulatory strategy.

• Support regulatory interactions: Serve as the CMC subject-matter expert during FDA meetings, prepare responses to technical and manufacturing questions, and provide scientifically supported recommendations to inform regulatory discussions and next steps.

• Manage risks and technical decisions: Investigate manufacturing and analytical challenges using scientific evidence, evaluate alternative approaches, and present well-supported recommendations. Maintain clear accountability for external deliverables while leaving final program decisions to the internal leadership team.

Requirements

• AAV gene therapy experience: Demonstrated experience taking an AAV gene therapy program through CMC development to a first-in-human Phase 1 clinical trial.

• Manufacturing expertise: Experience with triple-transfection HEK293 suspension processes and a strong understanding of AAV manufacturing, process development, and production considerations.

• Regulatory documentation: Experience writing or substantially contributing to Module 3 documentation for both pre-IND and IND applications, with the ability to prepare high-quality CMC briefing materials and support FDA interactions.

• CDMO and vendor management: Proven ability to manage external manufacturing partners, coordinate technical workstreams, resolve conflicts, track deliverables, and hold vendors accountable for quality and timelines.

• Technical breadth: Strong understanding of CMC activities, including upstream and downstream process development, analytical development, drug substance, drug product, release testing, and manufacturing supply chains.

• Scientific and analytical judgment: Ability to investigate complex technical questions, evaluate evidence, identify risks, and develop practical, scientifically justified recommendations.

• Project management: Excellent organizational and communication skills, with the ability to lead productive meetings, establish clear action plans, manage competing priorities, and deliver against aggressive milestones.

• Independent consulting capability: Comfortable working autonomously, managing a defined scope of work, and collaborating effectively with internal stakeholders and external partners in a remote environment.

• Preferred qualifications: Direct AAV CDMO management experience; multiple successful IND submissions and GMP manufacturing batches; GLP/GMP analytical development experience; experience advancing AAV programs into later-stage clinical trials or commercialization; knowledge of large-animal IND-enabling and toxicology studies; and strong regulatory judgment.

Benefits

• Competitive consulting engagement: Independent contractor arrangement with compensation and scope defined in a consulting agreement and Statement of Work.

• Flexible working hours: Approximately 20–40 hours per week, depending on the project phase, with scheduling flexibility around CDMO meetings and critical milestones.

• Remote work: Work remotely from the United States, with occasional travel for key project presentations and manufacturing activities.

• Travel expenses covered: Business travel to the project headquarters and the CDMO will be reimbursed.

• Independent consulting flexibility: Continue working with other clients, subject to applicable conflict-of-interest restrictions.

• High-impact scientific contribution: Help advance an innovative AAV gene therapy program toward clinical development and contribute to establishing a CMC strategy for a potentially transformative treatment.

• Defined project duration: Approximately six months, with an anticipated start in December 2026.

• Application deadline: October 30, 2026, with applications reviewed on a rolling basis.