Director, Biologics CMC Technical Writing

Responsibilities

• Lead the planning, authoring, and delivery of CMC content for 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.

Education/Experience Requirements

• Bachelor's degree in pharmaceutical sciences, chemical engineering, biotechnology, or a related discipline required. Equivalent combination of education and applicable job experience may be considered.
• M.S. or Ph.D. or other relevant advanced degree preferred.
• 10+ years of progressively relevant pharmaceutical or biotechnology industry experience required.
• Direct experience authoring CTD Module 2 and Module 3 content for at least one BLA, marketing application, or comparable late-stage biologics submission.
• Strong working experience with microbial fermentation, recombinant proteins, or bacterial expression systems required.
• Experience with lyophilized drug product, combination products, and device constituent components is highly desirable.
• Strong knowledge of biologics development, manufacturing, analytical control, process validation, scale up, comparability, stability, and commercial manufacturing.

Additional Skills/Experience

• The ideal candidate will embody Travere's core values: Courage, Community Spirit, Patient Focus and Teamwork.
• Driven, intelligent, passionate about making a difference for patients with rare diseases.
• Experience participating in FDA meetings, BLA review activities, regulatory information requests, or pre-approval inspections.
• Experience with delivery systems, design controls, human factors activities, and device related risk management.
• Advanced PowerPoint skills and experience preparing technical, regulatory, governance, and executive level presentations.
• Strategic thinker and strong cross functional collaborator.
• Clear and persuasive scientific communicator.
• Skilled at driving content decisions within a matrixed organization and managing compressed timelines with strong attention to detail.
• Committed to quality, accuracy, consistency, and regulatory compliance.
• Excellent decision-making and collaboration skills with strong attention to detail.
• Ability to travel 10% domestically and internationally.