AAV CMC Consultant (Independent Contractor)

Job description

**This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for an AAV CMC Consultant (Independent Contractor) based in the United States.** This is an opportunity to help advance an innovative adeno-associated virus (AAV) gene therapy program toward its first-in-human clinical trial. You will bring specialized Chemistry, Manufacturing, and Controls (CMC) expertise to a high-impact therapeutic development project targeting prevalent, age-related diseases. Working closely with an external Contract Development and Manufacturing Organization (CDMO), you will assess manufacturing readiness, define priorities, and drive execution against an ambitious timeline. Your expertise will shape process development, analytical strategy, manufacturing quality, and regulatory documentation. You will lead technical working meetings, translate complex challenges into actionable recommendations, and hold external partners accountable for agreed deliverables. The engagement combines scientific rigor, regulatory strategy, and hands-on project leadership in a flexible, remote consulting environment. This approximately six-month contract offers the opportunity to influence a pioneering gene therapy program as it progresses toward IND submission and first-in-human studies. ### 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