Director, Biologics CMC Technical Writing

Reference: 631384

Location, San Diego, CA – For positions listed as San Diego/Remote, our preference is for candidates who are based in the San Diego area. Those employees would typically work in a hybrid arrangement, coming into the office two days per week, with Tuesdays and Wednesdays generally being the preferred in-office days (although this may vary slightly by team).Target Base Pay Range:$189-246

Be a part of a global team that is inspired to make a difference in the lives of people living with rare disease. 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.

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 All positions have an essential job function to be able to perform face to face work with colleagues and/or onsite in San Diego. No role is expected to be 100% remote