AAV CMC Consultant (Independent Contractor)

Gordian Biotechnology

19h•Remote

About The Position

Gordian is seeking an experienced independent AAV CMC consultant to help advance its first gene therapy program toward first-in-human Phase 1. The consultant will assess the program’s CMC status, develop a prioritized strategy with the external CDMO, and lead working meetings to keep development and manufacturing on schedule and aligned with quality and material needs. The consultant will provide technical recommendations; Gordian retains final program decision-making authority. During the first month, the consultant will conduct a CMC gap analysis against the target product profile and provide a prioritized gap-closure plan. The consultant will also review the CDMO master services agreement and initial process development and manufacturing plan. Across the roughly six-month engagement, the consultant will guide upstream, downstream, and analytical development, including a phase-appropriate potency assay strategy; manage CDMO meetings and follow-up; and draft Module 3 content for pre-IND and IND submissions. The planned outcome by six months is delivery of material from the CDMO’s non-GMP engineering run for a GLP toxicology study, along with preparation of CMC briefing materials and participation as Gordian’s CMC expert in FDA meetings. This is an independent consulting engagement under a consulting agreement, with details to be set out in a Statement of Work. The consultant may continue working with other clients unless there is a conflict of interest. The project is expected to run for approximately six months, beginning in December 2026, at roughly 20–40 hours per week depending on project phase. Work is remote, with occasional travel to Gordian headquarters and the CDMO; travel expenses are covered.

Requirements

Have taken an AAV gene therapy through CMC to a first-in-human Phase 1 trial.
Have experience with a triple-transfection HEK293 suspension process.
Have managed external vendors, with strength in project management, conflict resolution, and maintaining timelines.
Have written or substantially contributed to Module 3 of a pre-IND and IND application.
Bring seasoned CMC judgment, make well-supported recommendations, and be comfortable holding a CDMO accountable for timelines and quality.
Use scientific evidence to resolve manufacturing questions.

Nice To Haves

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, including process development, analytical development, drug substance, drug product, and supply chain.
Taken an AAV into later-phase trials or commercialization.
Designed large-animal IND-enabling or toxicology studies.
Sharp regulatory judgment.

Responsibilities

Assess the program’s CMC status through a thorough gap analysis against the target product profile and deliver a prioritized plan for addressing identified gaps.
Review the CDMO master services agreement and initial process development and manufacturing plan from a technical perspective.
Set agendas and lead regular CDMO working meetings, documenting next steps, owners, and due dates, and following up until deliverables are completed.
Guide upstream, downstream, and analytical development, including a phase-appropriate potency assay strategy.
Provide well-supported recommendations on process, analytics, release, and manufacturing questions.
Hold the CDMO accountable for quality, timelines, and delivery of the required quantity of material.
Draft Module 3 content for the pre-IND and IND submissions.
Prepare CMC briefing materials and represent Gordian as its CMC expert in FDA meetings, addressing agency questions.
Help ensure the CDMO’s non-GMP engineering run delivers material for the GLP toxicology study by the six-month milestone.