Remote Director, Biologics CMC Technical Writing

Travere Therapeutics; Columbus (OH); Hybrid; USD 189,000 - 246,000; Full time

Job summary

Travere Therapeutics seeks a Director, Technical Operations (Biologics CMC Technical Writing) to lead the preparation of CMC documentation for regulatory submissions, including BLA. The role oversees content integration, timelines, and regulatory messaging across multiple SMEs and external partners.

The ideal candidate has extensive experience authoring Module 3 content for biologics, strong scientific judgment, and the ability to influence cross-functional teams towards timely submission

Qualifications

• Bachelor's degree in pharmaceutical sciences, chemical engineering, biotechnology, or related field required.
• MS/PhD preferred; extensive pharma/biotech experience.
• 10+ years in pharma/biotech; CTD Module 2/3 authoring for BLA or similar.
• Experience with microbial fermentation, recombinant proteins, or bacterial systems.

Responsibilities

• Lead planning, authoring, and delivery of CMC content for regulatory submissions (BLA).
• Translate complex data into regulator-ready narratives.
• Develop strategies, templates, and timelines for CMC submissions.
• Author sections on drug substance/product manufacturing, process development, analytics, and stability.

Skills

CMC Writing

Biologics

Regulatory Submissions

Leadership

Cross-functional Collaboration

Education

Bachelor's degree

MS/PhD preferred

Tools

Microsoft PowerPoint

Regulatory document mgmt

Job description

Travere Therapeutics seeks a Director, Technical Operations (Biologics CMC Technical Writing) to lead the preparation of CMC documentation for regulatory submissions, including BLA. The role oversees content integration, timelines, and regulatory messaging across multiple SMEs and external partners.

The ideal candidate has extensive experience authoring Module 3 content for biologics, strong scientific judgment, and the ability to influence cross-functional teams towards timely submission