Remote AAV CMC Consultant — Independent, 6-Month Project

Gordian Biotechnology; United States; Remote; USD 150,000 - 210,000; Full time

Benefits offered by this job

Remote work

Travel expenses covered

Six-month project

Job summary

Gordian Biotechnology seeks an independent CMC consultant to drive a first-of-its-kind gene therapy program. You will lead CMC strategy, manage external CDMOs, and push for timely, compliant material delivery while drafting Module 3 for regulatory submissions.

You’ll coordinate meetings, synthesize data, and translate complex science into actionable plans and FDA-ready briefs. Remote with occasional travel, six-month engagement starting December 2026.

Qualifications

• Experience leading CMC for gene therapy programs.
• Proven ability to manage external CDMOs with timelines.
• Written or substantially contributed to pre-IND/IND modules.

Responsibilities

• Lead CMC gap analyses against target product profile.
• Run CDMO meetings, define next steps and owners.
• Draft Module 3 content for pre-IND and IND submissions.
• Prepare CMC briefings for FDA meetings and interact with agency.

Skills

AAV gene therapy

CMC leadership

CDMO management

FDA interactions

Job description

Gordian Biotechnology seeks an independent CMC consultant to drive a first-of-its-kind gene therapy program. You will lead CMC strategy, manage external CDMOs, and push for timely, compliant material delivery while drafting Module 3 for regulatory submissions.

You’ll coordinate meetings, synthesize data, and translate complex science into actionable plans and FDA-ready briefs. Remote with occasional travel, six-month engagement starting December 2026.