AAV CMC Consultant (Independent Contractor)

📋 Description

• Assess CMC readiness and define strategy: Conduct a comprehensive CMC gap analysis against the
• Lead CDMO collaboration and project execution: Establish agendas and lead regular technical working
• Guide process and analytical development: Provide expert guidance on upstream and downstream AAV
• Oversee manufacturing readiness and material delivery: Coordinate with the CDMO to support the
• Develop regulatory CMC documentation: Draft and substantially contribute to Module 3 content for
• Support regulatory interactions: Serve as the CMC subject-matter expert during FDA meetings

🎯 Requirements

• AAV gene therapy experience: Demonstrated experience taking an AAV gene therapy program through CMC
• Manufacturing expertise: Experience with triple-transfection HEK293 suspension processes and a
• Regulatory documentation: Experience writing or substantially contributing to Module 3
• CDMO and vendor management: Proven ability to manage external manufacturing partners, coordinate
• Technical breadth: Strong understanding of CMC activities, including upstream and downstream
• Scientific and analytical judgment: Ability to investigate complex technical questions, evaluate

🎁 Benefits

• Competitive consulting engagement: Independent contractor arrangement with compensation and scope
• Flexible working hours: Approximately 20–40 hours per week, depending on the project phase, with
• Remote work: Work remotely from the United States, with occasional travel for key project
• Travel expenses covered: Business travel to the project headquarters and the CDMO will be
• Independent consulting flexibility: Continue working with other clients, subject to applicable
• High-impact scientific contribution: Help advance an innovative AAV gene therapy program toward