AAV CMC Consultant (Independent Contractor)
New
J
JobgetherGene therapy
Based in the United StatesContract
Salary not disclosed
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Job Details
- Required Skills
- Project Management
Requirements
- Demonstrated experience taking an AAV gene therapy program through CMC development to a first-in-human Phase 1 clinical trial.
- Experience with triple-transfection HEK293 suspension processes and a strong understanding of AAV manufacturing and production considerations.
- Experience writing or substantially contributing to Module 3 documentation for pre-IND and IND applications.
- Ability to prepare CMC briefing materials and support FDA interactions.
- Proven ability to manage external manufacturing partners, coordinate technical workstreams, resolve conflicts, track deliverables, and hold vendors accountable.
- Strong understanding of upstream and downstream process development, analytical development, drug substance, drug product, release testing, and manufacturing supply chains.
- Ability to investigate technical questions, evaluate evidence, identify risks, and develop scientifically justified recommendations.
- Ability to lead meetings, establish action plans, manage competing priorities, and deliver against milestones.
- Comfortable working autonomously, managing a defined scope of work, and collaborating with internal stakeholders and external partners remotely.
- Preferred: direct AAV CDMO management experience, multiple successful IND submissions and GMP manufacturing batches, or GLP/GMP analytical development experience.
- Preferred: experience advancing AAV programs into later-stage clinical trials or commercialization, knowledge of large-animal IND-enabling and toxicology studies, and strong regulatory judgment.
Responsibilities
- Conduct a CMC gap analysis against the target product profile, identify technical and regulatory risks, and develop a prioritized plan.
- Review the CDMO master services agreement and process development and manufacturing plans, and provide practical recommendations.
- Lead technical working meetings, document decisions and action items, assign owners and deadlines, and follow up on deliverables.
- Monitor project progress, resolve issues, escalate risks, and maintain momentum against milestones.
- Guide upstream and downstream AAV manufacturing, analytical development, product characterization, and release strategies.
- Coordinate with the CDMO to support a non-GMP engineering run and delivery of material for the GLP toxicology study.
- Draft and contribute to Module 3 content for pre-IND and IND submissions and prepare CMC briefing materials.
- Serve as the CMC subject-matter expert during FDA meetings and prepare responses to technical and manufacturing questions.
- Investigate manufacturing and analytical challenges, evaluate alternatives, and present scientifically supported recommendations.
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