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AAV CMC Consultant (Independent Contractor)

US · Remote · Contract · Others

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About the role

Manufacturing
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.