AAV CMC Consultant (Independent Contractor)

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.

• 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.