Director, Biologics CMC Technical Writing

Department: 106800 Technical Operations

Location:

San Diego, USA
- Remote

At Travere Therapeutics, we recognize that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of rare patients.

Our work is rewarding - both professionally and personally - because we are making a difference. We are passionate about what we do.

We are seeking talented individuals who will thrive in our collaborative, diverse, fast-paced environment and share in our mission - to identify, develop and deliver life-changing therapies to people living with rare disease. We stick by our values centered on patients, courage, community, and collaboration to pursue our vision of becoming a leading biopharmaceutical company dedicated to the delivery of innovation and hope to patients in the global rare disease community.

At Travere Therapeutics, we are in rare for life. We continue to courageously forge new paths as we move toward a common goal of elevating science and service for rare patients.

The Director, Technical Operations (Biologics CMC Technical Writing) is responsible for the preparation of Chemistry, Manufacturing, and Controls (CMC) documentation for regulatory submissions, including Biologics License Application (BLA). This individual leads the development and execution of the CMC submission strategy in collaboration with Regulatory Affairs and technical subject matter experts (SME) and directs the preparation of high-quality, scientifically rigorous content that clearly communicates the product's development history, manufacturing process, control strategy, and commercial readiness.

The ideal candidate has extensive experience authoring Module 3 content for biologics products, with particular expertise in drug substance production. This role requires strong scientific judgment, excellent writing skills, and the ability to influence and drive decisions across technical SMEs, Regulatory Affairs, Quality, Manufacturing, Project Management, and external partners. The Director serves as the Technical Operations leader for CMC content integration, advises governance on submission readiness and material risks, and drives timely resolution of technical or content gaps supporting the corporate goals for development and commercialization of a combination product for a rare disease indication.

• Lead the planning, authoring, and delivery of CMC content for the regulatory submissions such as the BLA, including relevant CTD Module 2 summaries and Module 3 sections.
• Translate complex technical data into clear, concise, accurate, and regulator-ready narratives.
• Develop document strategies, content plans, timelines, templates, and authoring standards for the CMC submission.
• Author and coordinate sections covering:
  • Drug substance and drug product manufacturing processes
  • Process development, characterization, validation, and control strategies
  • Microbial fermentation and downstream purification
  • Product and process characterization
  • Specifications, analytical procedures, and method validation
  • Formulation and lyophilization development
  • Container closure systems
  • Stability programs and proposed shelf life
  • Manufacturing comparability and lifecycle changes
• Ensure consistency across Module 3 sections and alignment with the Quality Overall Summary, regulatory strategy, source reports, and supporting data.
• Lead cross-functional authoring and decision-making forums, reconcile differing technical perspectives, establish key regulatory messages, and drive timely resolution of technical and content gaps.
• Identify submission risks, data gaps, inconsistencies, and potential regulatory questions early in the authoring process.
• Manage document reviews, comment resolution, version control, and approval workflows.
• Support responses to FDA information requests and other regulatory questions during BLA review.
• Collaborate with internal teams, contract manufacturers, testing laboratories, consultants, and other external partners.
• Prepare clear and effective PowerPoint presentations for governance meetings, regulatory interactions, technical reviews, and executive updates.
• Establish sustainable CMC authoring best practices.
• Additional duties as needed.

• Bachelor's degree in pharmaceutical sciences, chemical engineering, biotechnology, or a related discipline required. Equivalent…