Senior Director, Technical Operations

Travere Therapeutics • San Diego, CA

9h • Remote

About The Position

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.

Requirements

• Bachelor’s degree in Life Sciences, Chemistry, Pharmaceutical Sciences, Biochemistry, Chemical Engineering, or a related discipline required. Equivalent combination of education and applicable job experience may be considered
• 12+ years of relevant experience (depending on degree) in small molecule API development and manufacturing with emphasis on late-phase clinical development, scale-up, and commercialization
• Expert knowledge and extensive CMC experience advancing small molecule APIs from process development through process characterization, PPQ, commercialization, and tech transfers in support of solid oral dosage form programs
• Extensive experience managing global CDMOs, third-party manufacturers, and testing labs.
• Broad knowledge and experience with phase-appropriate cGMP requirements and applicable US, EU, and ICH guidelines
• Demonstrated ability to prepare and review CMC sections of regulatory filings, including INDs, IMPDs, and NDAs

Nice To Haves

• M.S., Ph.D., or other advanced degree in a related discipline preferred
• 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
• Strong professional experience in a similar role within the pharmaceutical industry, preferably in small molecule development and manufacturing for solid oral dosage forms
• Successful record of creating and managing complex project plans, timelines, budgets, and development and execution 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
• Team player and strong interpersonal and organizational skills and excellent verbal and written communication skills
• Excellent decision-making and collaboration skills with strong attention to detail
• Six Sigma and statistical knowledge is a plus

Responsibilities

• Provide technical oversight of API production, scale up, process characterization, and process performance qualification (PPQ) for a small molecule, solid oral drug product manufactured at Travere CDMOs.
• Serve as the senior technical decision authority for assigned programs, evaluating complex technical, regulatory, supply, quality, and financial tradeoffs and recommending actions to senior and executive leadership.
• Establish, review and approve manufacturing-related documentation, including change notifications, batch records, process development, tech transfer, process characterization, and validation protocols/reports.
• Verify suitability, qualification, and validation status of processes at CDMOs and other external laboratories.
• Establish technical direction and provide senior-level leadership and oversight of GMP quality management systems, including deviations, investigations, CAPAs, change controls, regulatory submissions, and facility inspections.
• Lead and influence internal and external project teams to support CMC development, clinical supply, commercialization, and lifecycle management of small molecule drug products.
• Author and review technical documents and regulatory submission content, including INDs, IMPDs, and NDAs.
• Maintain up-to-date knowledge of US and EU GMP requirements, ICH guidelines, and other regulatory expectations applicable to pharmaceutical development and manufacturing.
• Review project scope, timelines, and deliverables to ensure CDMO activities meet contractual obligations, quality standards, and program objectives.
• Additional duties assigned as needed.

Benefits

• premium health, financial, work-life and well-being offerings for eligible employees and dependents
• wellness and employee support programs
• life insurance
• disability
• retirement plans with employer match
• generous paid time off
• company stock

What This Job Offers

• Job Type: Full-time
• Career Level: Director