Associate Director, Technical Operations (San Diego, CA or Remote)

Role Details

Department: 106800 Technical Operations Location: San Diego, USA- Remote 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. Position Summary: The Associate Director, Technical Operations is responsible for managing the upstream drug substance development, manufacturing, and scale up activities of a biologics product at the CDMOs, serving as a technical subject matter expert on upstream production (USP) for Travere. This position collaborates closely with colleagues in Technical Operations, Quality, and Regulatory, supporting the corporate goals for clinical development to commercialization of a biologics drug product for a rare disease indication. Responsibilities: Technical oversight of the tech transfer, scale up, and manufacturing for the upstream drug substance production of biological products at Travere\'s CDMOs. Provide technical review and approval for manufacturing related documents including change notifications, batch records, process development, tech transfer, and validation protocols/reports, for upstream drug substance production. Verify suitability, qualification, and validation of upstream processes at CDMOs and other external laboratories. Provide technical support for quality systems governing GMP manufacturing including deviations, investigations, CAPAs, change controls, regulatory submissions, and facility inspections. Provide CMC development and manufacturing support on internal and external project teams. Maintain up-to-date knowledge of US and EU GMPs and other regulatory guidance applicable to pharmaceutical production. Write USP technical reports on a variety of process development related subjects. Assist in preparation of CMC sections of regulatory submissions for USP. Education/Experience Requirements: B.S. degree in Biochemistry, Chemistry, Chemical Engineering, or other related discipline. Equivalent combination of education and applicable job experience may be considered. 8 years of relevant experience including biologics manufacturing, scale-up, and late stage drug development. Additional Skills/Experience: Manufacturing experience with upstream drug substance production of biologics; microbial fermentation is a plus. Expert knowledge in process development, QbD, validation and technology transfer procedures. Strong professional experience in a similar role within the pharmaceutical industry, preferably in biologics development. Broad knowledge and experience within the GMP environment and regulatory affairs. Successful record of creating and managing complex project plans, timelines, and budgets, and development of risk mitigation strategies. Ability to adapt to modification and changes to project plans, demonstrating flexibility to implement new strategies and tactics to accommodate these changes. Strong interpersonal and organizational skills and exce

Travere Therapeutics, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.