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:

Sound like you? Send the following to linda@gordian.bio:

• CV (no page limit)
• Relevant past experience: If available, please include short summaries (excluding proprietary information) of similar projects in CMC guidance you’ve completed. 

• Why you are a good fit for this engagement at Gordian (no more than 400 words) 
• Conflict of interest disclosure: Please disclose any current consulting, advisory, employment, or financial relationships that could reasonably overlap with Gordian’s therapeutic areas (e.g., osteoarthritis,  metabolic disease, heart failure, lung fibrosis). 

• Future interest (optional, not used in evaluation): Please indicate whether you would be open to being contacted in the future about potential full-time CMC roles at Gordian. This information is requested solely for long-term planning. It will not be used in evaluating proposals or selecting consultants for this engagement.

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.