Associate Director, Technical Operations - Drug Product

Be part of a global team 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, delivering rewarding work both professionally and personally. We are passionate about our mission to identify, develop, and deliver life-changing therapies.

We uphold values centered on patients, courage, community, and collaboration as we pursue our vision of becoming a leading biopharmaceutical company dedicated to innovation and hope for the global rare disease community.

About the role

The Associate Director, Technical Operations – Drug Product, is responsible for drug product manufacturing, scale-up, validation, and commercialization of a small molecule, solid oral drug product. This role involves managing external CDMOs and collaborating closely with colleagues in Technical Operations, Quality, Regulatory CMC, Clinical, and Supply Chain. It is a key CMC contributor for clinical development through commercialization of a small molecule drug product for a rare disease indication.

Responsibilities

• Technical oversight of production, scale-up, process characterization, and process performance qualification (PPQ) of drug product manufacture of a small molecule, solid oral product at Travere’s CDMOs.
• Review and approve manufacturing-related documents including change notifications, batch records, process development, tech transfer, process characterization, 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.
• Collaborate on CMC development and commercialization of drug product with internal and external project teams.
• Author and review technical documents and regulatory filings, including INDs, IMPDs, and NDAs.
• Maintain up-to-date knowledge of US and EU GMPs and other regulatory guidance applicable to pharmaceutical production.
• Review project scope and ensure that contractual obligations of CDMOs meet quality standards and timelines.
• Provide technical recommendations to leadership regarding CDMO performance, process readiness, validation strategy, regulatory risks, and commercialization milestones.
• Additional duties as assigned.

Requirements

• Bachelor’s degree in Chemistry, Pharmaceutical Sciences, Biochemistry, Chemical Engineering, or other related discipline required. Equivalent combination of education and applicable job experience may be considered.
• Advanced degree (M.S. or Ph.D.) in Chemical Engineering, Biomedical Engineering, Biotechnology, Biochemistry, or related disciplines preferred.
• 8+ years of relevant work experience including small molecule drug product manufacturing with a focus on scale-up, late-phase clinical development, and commercialization.
• Manufacturing experience with amorphous solid dispersions (spray dried amorphous dispersions preferred); solid oral drug product (granulation, capsules, and tablets) development experience a plus.
• Expert knowledge in process development, characterization studies, PPQ, and commercialization for solid oral products, with emphasis on amorphous solid dispersions.
• Skilled in preparation of CMC modules of regulatory filings such as INDs, IMPDs, and NDAs.
• Extensive experience managing global CDMOs and/or third-party manufacturers and testing labs.
• Broad knowledge and experience with phase-appropriate cGMP requirements and US, EU, and ICH guidelines.

Skills

• Driven, intelligent, and 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 solid oral development and manufacturing.
• Successful record of creating and managing complex project plans, timelines, and budgets, and development of risk mitigation strategies.
• Ability to adapt to modifications and changes to project plans, demonstrating flexibility to implement new strategies and tactics.
• Team player with 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.
• Ability to travel 10-20% domestically and internationally.
• All positions require the ability to perform face-to-face work with colleagues and/or onsite in San Diego; no role is 100% remote.

Benefits

• Premium health, financial, work-life, and well-being offerings for eligible employees and dependents.
• Wellness and employee support programs.
• Life insurance and disability coverage.
• Retirement plans with employer match.
• Generous paid time off.

Pay

Target base pay range: $150,000.00 - $195,000.00. Actual pay offered will depend on experience, education, skills, and location. The compensation package includes a combination of cash (base pay and short-term incentive) and long-term incentive compensation (company stock).