Associate Director, Technical Operations/CMC-Biologics

Company: Travere Therapeutics
Location: San Diego
Posted on: April 8, 2021

Job Description:

Associate Director, Technical Operations/CMC-Biologics Department:106800 Technical OperationsLocation:San Diego 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 drug substance and drug product development, manufacturing, and scale up activities of a biologics product at the CDMOs, serving as a technical subject matter expert 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 of a biological product 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.--
• Verify suitability, qualification, and validation of 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 technical reports on a variety of process development related subjects.
• Assist in preparation of CMC sections of regulatory submissions.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 microbial production, PEGylation, aseptic fill/finish, and lyophilization 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 excellent verbal and written communication skills are required.
    • Excellent decision-making and collaboration skills with strong attention to detail.
    • Six Sigma and statistical knowledge is a plus.
    • Ability to travel 10-20% domestically and internationally. Travere Therapeutics, Inc. is an EEO/AA/Veteran/Disability Employer Posted 3 Days Ago Full time R-100098 About Us Travere Therapeutics is a biopharmaceutical company with a global team dedicated to working with the rare disease community to identify, develop and deliver life-changing therapies. The Company's development efforts are led by sparsentan, a product candidate in late-stage development for focal segmental glomerulosclerosis (FSGS) and IgA nephropathy (IgAN) - rare kidney disorders that often lead to end-stage kidney disease. The company is also advancing TVT-058 for the treatment of classical homocystinuria, a genetic metabolic disorder that can cause life-threatening thrombotic events. Travere Therapeutics' early research efforts include partnering with leaders in patient advocacy and government research to identify potential therapeutics for NGLY1 deficiency and Alagille syndrome, conditions with no approved treatment options. The Company also delivers four FDA-approved therapies, Chenodal--, Cholbam--, Thiola-- and Thiola EC--, and is committed to ensuring broad access, educational and financial support for patients. For more information, visit travere.com.

Keywords: Travere Therapeutics, San Diego , Associate Director, Technical Operations/CMC-Biologics, IT / Software / Systems , San Diego, California