Director, Biologics CMC Technical Writing (Remote)

Travere Therapeutics; Washington (District of Columbia); Remote; USD 189,000 - 246,000; Full time

Job summary

Travere Therapeutics is seeking a Director of Technical Operations (Biologics CMC Technical Writing) to lead regulatory submissions. You will author Module 3 content, oversee strategy with Regulatory Affairs and SMEs, and drive high-quality narratives communicating development history, manufacturing, and control strategies.

The role requires extensive experience in biologics, strong scientific judgment, and the ability to influence across departments and with external partners.

Qualifications

• Bachelor’s in pharma sciences, chemical engineering, biotechnology, or related field.
• 10+ years of relevant pharma/biotech experience.
• Direct CTD Module 2 and Module 3 authoring for at least one BLA or late-stage biologics submission.
• Experience with microbial fermentation, recombinant proteins, or bacterial expression systems.
• Knowledge of biologics development, manufacturing, analytics, validation, scale-up.

Responsibilities

• Lead planning, authoring, and delivery of CMC content for regulatory submissions like the BLA.
• Translate complex data into regulator-ready narratives.
• Develop document strategies, content plans, timelines, templates, and authoring standards.
• Coordinate sections on drug substance/product manufacturing, process validation, and stability.
• Lead cross-functional reviews and drive timely resolution of gaps.

Skills

Regulatory writing

Cross-functional collaboration

Strategic thinking

Scientific communication

Attention to detail

Leadership

Education

Bachelor's degree in pharmaceutical sciences

MS/PhD preferred

Tools

PowerPoint

Job description

Travere Therapeutics is seeking a Director of Technical Operations (Biologics CMC Technical Writing) to lead regulatory submissions. You will author Module 3 content, oversee strategy with Regulatory Affairs and SMEs, and drive high-quality narratives communicating development history, manufacturing, and control strategies.

The role requires extensive experience in biologics, strong scientific judgment, and the ability to influence across departments and with external partners.