AAV CMC Consultant (Independent Contractor)

Gordian is a therapeutics company whose mission is to cure age-related disease. Our Mosaic Screening platform pools interventions in living animals, giving causal validation for hundreds of targets at once. You can read more on our website and in our preprint.

The engine is working. We have results across six disease areas and have mapped nearly as many targets as the field reported in 20 years. A novel osteoarthritis candidate is in IND-enabling studies, and we've started an obesity drug-discovery collaboration with Pfizer. Now we're taking our first AAV program toward the clinic, and what we do here will set the precedent for gene therapies in prevalent disease.

We're looking for an AAV CMC expert to help take our first gene therapy program to first-in-human, on an aggressive timeline. You'll size up where our CMC stands, shape our strategy with our external CDMO, and run the regular working meetings that keep the CDMO moving fast and delivering the right quality and quantity of material, on time. You bring the expertise and the recommendations; Gordian makes the final program calls.

This is a hands-on engagement, not a name on a slide. You'll set the agenda for CDMO meetings, bring sharp recommendations on process, analytics, and release, turn every meeting into clear next steps, and follow up until the CDMO delivers, pushing timelines when they need pushing. How you get there is up to you.

• Taken an AAV gene therapy through CMC to a first-in-human Phase 1 trial
• Experience with a triple-transfection HEK293 suspension process
• Managed external vendors with strength in project management, conflict resolution, and holding timelines.
• Written or substantially contributed to Module 3 of a pre-IND and IND application

• Directly managed CDMOs for AAV manufacturing
• Taken multiple products through successful INDs and GMP batches
• Experience with analytical development in a GLP/GMP setting
• Broad fluency across CMC: process development, analytical development, drug substance, drug product, and supply chain
• Taking an AAV into later-phase trials or commercialization
• Designing large-animal IND-enabling or toxicology studies
• Sharp regulatory judgment

• Independent consulting. You'll work as an independent contractor under a consulting agreement, with the specifics set out in a Statement of Work once we've found the right fit. You're free to keep working with your other clients barring any conflict of interest.
• Timing. A project of roughly six months, kicking off in December 2026.
• Flexible hours. Roughly 20–40 hours a week depending on the phase, on your own schedule around CDMO meetings and milestones.
• Remote, with occasional trips to Gordian HQ to present major deliverables and to the CDMO as manufacturing ramps up. Travel expenses are covered.

Application Due Date: 10/30 and will be evaluated on a rolling basis

If you want to guide a first-of-its-kind gene therapy to the clinic, we'd love to hear from you.