AAV CMC Consultant – Independent Contractor

This is a fully remote position, open to applicants in United States.

📋 Description

• Evaluate the current CMC readiness in relation to the target product profile.

• Provide a prioritized strategy to address identified CMC gaps within the first month.

• Review the master services agreement with the CDMO and the initial process development and manufacturing plan.

• Conduct regular working meetings with the CDMO and establish agendas.

• Oversee upstream, downstream, and analytical development efforts.

• Formulate a potency assay strategy that aligns with the project's current phase.

• Transform meeting outcomes into written action items with designated owners and deadlines.

• Monitor and advocate for CDMO deliverables, timelines, and quality standards.

• Compose Module 3 for the pre-IND package and IND submissions.

• Ensure the non-GMP engineering run by the CDMO produces material for the GLP-tox study within six months.

• Prepare the CMC briefing and represent Gordian in discussions with the FDA.

• Provide well-supported CMC recommendations while Gordian makes final program decisions.

⛳️ Requirements

• Independent CMC consultant with prior experience guiding an AAV gene therapy through CMC to a first-in-human Phase 1 trial.

• Familiarity with a triple-transfection HEK293 suspension process.

• Proven experience in managing external vendors, including project management, conflict resolution, and maintaining timelines.

• Authored or significantly contributed to Module 3 of a pre-IND or IND application.

• Directly managed CDMOs for AAV manufacturing (bonus).

• Successfully navigated multiple products through INDs and GMP batches (bonus).

• Experience with analytical development in GLP/GMP environments (bonus).

• Extensive knowledge across CMC: process development, analytical development, drug substance, drug product, and supply chain (bonus).

• Experience advancing an AAV into later-phase trials or commercialization (bonus).

• Expertise in designing large-animal IND-enabling or toxicology studies (bonus).

• Strong regulatory judgment (bonus).

• Capability to work as an independent contractor under a consulting agreement.

• Availability for approximately 20–40 hours per week, depending on the project phase.

• Willingness to travel occasionally to Gordian HQ and the CDMO.

• Must be eligible to work in the United States.

🏝️ Benefits

• Travel expenses are reimbursed.

• Flexible hours and the ability to create your schedule around CDMO meetings and milestones.

• Opportunity for remote work.

• Independent consulting arrangement that allows work with other clients, barring conflicts of interest.