AAV CMC Lead Consultant (Independent Contractor)

Gordian; United States; Remote; USD 207.000 - 344.000; Teilzeit

Zusammenfassung

Gordian is seeking an experienced AAV CMC consultant to drive the first gene therapy program from CDMO kickoff to first-in-human. This independent engagement challenges you to size the CMC gaps, shape strategy with external partners, and manage the cadence of CDMO meetings to deliver quality material on schedule.

In this six-month engagement (starting December 2026), you will own the agenda, push for aggressive timelines, and draft Module 3 for the pre-IND and IND submissions.

Qualifikationen

• Taken an AAV gene therapy through CMC to a first-in-human Phase 1 trial.
• Experience coordinating with external CDMOs on process development and manufacturing.
• Proven project management skills with trackable timelines and milestones.
• Written or substantially contributed to Module 3 of a pre-IND/IND package.

Aufgaben

• Conduct a thorough CMC gap analysis in month 1 and deliver a prioritized plan for closing gaps.
• Lead CDMO meetings, assign owners and due dates, and chase deliverables to ensure timely completion.
• Draft Module 3 content for pre-IND and IND submissions and support FDA interactions as the CMC expert.
• Hold CDMOs to timelines and quality, providing sharp, data-driven recommendations.

Kenntnisse

AAV CMC

CDMO coordination

Project management

Regulatory strategy

Independent contractor

Jobbeschreibung

Gordian is seeking an experienced AAV CMC consultant to drive the first gene therapy program from CDMO kickoff to first-in-human. This independent engagement challenges you to size the CMC gaps, shape strategy with external partners, and manage the cadence of CDMO meetings to deliver quality material on schedule.

In this six-month engagement (starting December 2026), you will own the agenda, push for aggressive timelines, and draft Module 3 for the pre-IND and IND submissions.