Associate Director, Technical Operations (Small Molecule CMC)
Travere Therapeutics
August 20, 2026
Remote friendly (United States)
United States
Operations
Position Summary:
The Associate Director, Technical Operations (Small Molecule CMC) will provide technical oversight for small molecule API development and manufacturing activities conducted at Travere CDMOs, supporting CMC development, clinical manufacturing, commercial launch planning, logistics, and lifecycle management.
Responsibilities:
- Provide technical oversight of API production, scale up, process characterization, and PPQ for a small molecule solid oral drug product manufactured at CDMOs.
- Review and approve manufacturing-related documentation (change notifications, batch records, process development, tech transfer, characterization, and validation protocols/reports).
- Verify suitability, qualification, and validation status of processes at CDMOs and external laboratories.
- Support GMP quality management systems (deviations, investigations, CAPAs, change controls, regulatory submissions, facility inspections).
- Collaborate with internal/external teams for CMC development, clinical supply, commercialization, and lifecycle management.
- Author/review technical documents and regulatory submissions (INDs, IMPDs, NDAs).
- Maintain knowledge of US/EU GMP and ICH guidelines.
- Review scope, timelines, and deliverables to ensure contractual and quality alignment.
Education/Experience Requirements:
- B.S. required (chemistry/biochemistry/pharmaceutical science/chemical engineering or related). M.S./Ph.D preferred.
- 8+ years’ relevant experience (late-phase clinical development, scale-up, commercialization).
- Expert knowledge in small-molecule API process development, characterization, PPQ, and commercialization for solid oral formulations.
- Experience managing/overseeing CDMOs and contract testing labs (global sites preferred).
- Broad knowledge of phase-appropriate cGMP and US/EU/ICH guidance.
- Ability to prepare/review CMC sections of INDs/IMPDs/NDAs.
Additional Skills/Experience:
- Demonstrate Courage, Community Spirit, Patient Focus, and Teamwork.
- Strong project planning (timelines, budgets, risk mitigation) and adaptability to change.
- Strong communication, decision-making, collaboration, and attention to detail.
- Six Sigma/statistical knowledge plus.
- Travel 10–20%.
- Ability to perform onsite/face-to-face work in San Diego (not 100% remote).
Benefits:
- Premium health, financial/work-life well-being offerings, wellness/support programs, life insurance, disability, retirement with match, and generous paid time off.
Compensation:
- Target base pay range: $150,000.00–$195,000.00.
Application Instructions:
- Travere will accept applications on an ongoing basis until a candidate is selected.
The Associate Director, Technical Operations (Small Molecule CMC) will provide technical oversight for small molecule API development and manufacturing activities conducted at Travere CDMOs, supporting CMC development, clinical manufacturing, commercial launch planning, logistics, and lifecycle management.
Responsibilities:
- Provide technical oversight of API production, scale up, process characterization, and PPQ for a small molecule solid oral drug product manufactured at CDMOs.
- Review and approve manufacturing-related documentation (change notifications, batch records, process development, tech transfer, characterization, and validation protocols/reports).
- Verify suitability, qualification, and validation status of processes at CDMOs and external laboratories.
- Support GMP quality management systems (deviations, investigations, CAPAs, change controls, regulatory submissions, facility inspections).
- Collaborate with internal/external teams for CMC development, clinical supply, commercialization, and lifecycle management.
- Author/review technical documents and regulatory submissions (INDs, IMPDs, NDAs).
- Maintain knowledge of US/EU GMP and ICH guidelines.
- Review scope, timelines, and deliverables to ensure contractual and quality alignment.
Education/Experience Requirements:
- B.S. required (chemistry/biochemistry/pharmaceutical science/chemical engineering or related). M.S./Ph.D preferred.
- 8+ years’ relevant experience (late-phase clinical development, scale-up, commercialization).
- Expert knowledge in small-molecule API process development, characterization, PPQ, and commercialization for solid oral formulations.
- Experience managing/overseeing CDMOs and contract testing labs (global sites preferred).
- Broad knowledge of phase-appropriate cGMP and US/EU/ICH guidance.
- Ability to prepare/review CMC sections of INDs/IMPDs/NDAs.
Additional Skills/Experience:
- Demonstrate Courage, Community Spirit, Patient Focus, and Teamwork.
- Strong project planning (timelines, budgets, risk mitigation) and adaptability to change.
- Strong communication, decision-making, collaboration, and attention to detail.
- Six Sigma/statistical knowledge plus.
- Travel 10–20%.
- Ability to perform onsite/face-to-face work in San Diego (not 100% remote).
Benefits:
- Premium health, financial/work-life well-being offerings, wellness/support programs, life insurance, disability, retirement with match, and generous paid time off.
Compensation:
- Target base pay range: $150,000.00–$195,000.00.
Application Instructions:
- Travere will accept applications on an ongoing basis until a candidate is selected.