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Ready to guide the CMC path for one of the first gene therapies built for a prevalent, age-related disease, from CDMO kickoff to first-in-human?
The Journey and Destination:
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 ourwebsite and in ourpreprint.
The engine is working. We have results across six disease areas and have mappednearly as many targets as the field reported in 20 years. Anovel osteoarthritis candidate is in IND-enabling studies, and we've started an obesitydrug-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.
The Project
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.
What You'll Deliver:
In the first month, you'll run a thorough CMC gap analysis against our target product profile and hand us a prioritized plan for closing any gaps you find. You'll also bring your technical eye to our CDMO master services agreement and the initial process development and manufacturing plan.
Through months 1–6, you'll run the CDMO working meetings, turn each one into written next steps with owners and due dates, and chase deliverables to the finish line. You'll guide upstream, downstream, and analytical development, including a phase-appropriate potency assay strategy, and draft Module 3 for our pre-IND package so we get the most out of our FDA interaction.
By six months, the CDMO's non-GMP engineering run will have delivered material for our GLP-tox study, and you'll have drafted Module 3 content for our pre-IND and IND submissions. You'll prepare the CMC briefing and walk into FDA meetings as our CMC expert, ready to take the agency's questions.
And You
You're an independent CMC consultant who has done this before and wants to do it again on something first-of-its-kind. You bring the judgment of a seasoned CMC pro, make well-supported recommendations, and are comfortable holding a CDMO accountable to timelines and quality. When a manufacturing question needs an answer, you go back to the science to settle it.
You must have:
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
Bonus points if you have:
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
The Details:
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.
