[Hiring] AAV CMC Consultant @Gordian Biotechnology

Role Description

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.

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:
  • Run a thorough CMC gap analysis against our target product profile and hand us a prioritized plan for closing any gaps you find.
  • Bring your technical eye to our CDMO master services agreement and the initial process development and manufacturing plan.
• Through months 1–6:
  • Run the CDMO working meetings, turning each one into written next steps with owners and due dates, and chase deliverables to the finish line.
  • Guide upstream, downstream, and analytical development, including a phase-appropriate potency assay strategy.
  • Draft Module 3 for our pre-IND package to maximize our FDA interaction.
• By six months:
  • The CDMO's non-GMP engineering run will have delivered material for our GLP-tox study.
  • Draft Module 3 content for our pre-IND and IND submissions.
  • Prepare the CMC briefing and walk into FDA meetings as our CMC expert, ready to take the agency's questions.

Qualifications

• Independent CMC consultant with prior experience.
• Judgment of a seasoned CMC professional.
• Comfortable holding a CDMO accountable to timelines and quality.
• Ability to return to the science for manufacturing questions.

Requirements

• 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.

Benefits

• Independent consulting.
• Work as an independent contractor under a consulting agreement.
• Flexible hours: roughly 20–40 hours a week depending on the phase.
• Remote work with occasional trips to Gordian HQ and the CDMO.
• Travel expenses covered.

Application

Sound like you? Send the following to [email protected] :

• CV (no page limit)
• Relevant past experience: 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: disclose any current consulting, advisory, employment, or financial relationships that could reasonably overlap with Gordian’s therapeutic areas.
• Future interest (optional, not used in evaluation): indicate whether you would be open to being contacted in the future about potential full-time CMC roles at Gordian.

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.