Associate Director, Technical Operations (Small Molecule CMC)
Travere Therapeutics
August 20, 2026
Remote friendly (San Diego Metropolitan Area)
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. The role supports product development, clinical manufacturing, commercial launch planning, logistics, and lifecycle management of small molecule drug products. Partners with Quality, Regulatory Affairs, Clinical, and Supply Chain to ensure alignment, risk management, and milestone achievement.
Responsibilities:
- Provide technical oversight of API production, scale up, process characterization, and PPQ for solid oral drug products manufactured at CDMOs.
- Review/approve manufacturing documentation: change notifications, batch records, process development, tech transfer, process characterization, validation protocols/reports.
- Verify suitability, qualification, and validation status of processes at CDMOs and external laboratories.
- Support GMP quality systems (deviations, investigations, CAPAs, change controls, regulatory submissions, facility inspections).
- Collaborate to support CMC development, clinical supply, commercialization, and lifecycle management.
- Author/review technical documents and regulatory content (INDs, IMPDs, NDAs).
- Maintain knowledge of US/EU GMP, ICH guidelines, and regulatory expectations.
- Review scope, timelines, and deliverables to meet contractual, quality, and program objectives.
Education/Experience Requirements:
- B.S. in chemistry/biochemistry/pharmaceutical science/chemical engineering or related life sciences (M.S./Ph.D preferred).
- 8+ years relevant experience emphasizing late-phase development, scale-up, and commercialization.
- Expert knowledge of small molecule API process development/characterization, PPQ, and commercialization for solid oral formulations.
- Experience overseeing CDMOs and contract testing labs (preferably global).
- Broad knowledge of phase-appropriate cGMP and US/EU/ICH guidelines.
- Experience preparing/reviewing CMC sections of IND/IMPD/NDA filings.
Additional Skills/Experience:
- Strong communication, organizational, decision-making, collaboration, and attention to detail.
- Six Sigma/statistics knowledge plus.
- Travel 10–20% domestically/internationally.
- Ability to perform face-to-face/onsite work in San Diego; role not 100% remote.
Total Rewards Offerings (Benefits):
- Premium health, financial, work-life/well-being offerings; wellness and employee support programs; life insurance; disability; retirement plans with employer match; generous paid time off.
Application Instructions:
- Travere will accept applications on an ongoing basis until a candidate is selected for the position.
The Associate Director, Technical Operations (Small Molecule CMC) will provide technical oversight for small molecule API development and manufacturing activities conducted at Travere CDMOs. The role supports product development, clinical manufacturing, commercial launch planning, logistics, and lifecycle management of small molecule drug products. Partners with Quality, Regulatory Affairs, Clinical, and Supply Chain to ensure alignment, risk management, and milestone achievement.
Responsibilities:
- Provide technical oversight of API production, scale up, process characterization, and PPQ for solid oral drug products manufactured at CDMOs.
- Review/approve manufacturing documentation: change notifications, batch records, process development, tech transfer, process characterization, validation protocols/reports.
- Verify suitability, qualification, and validation status of processes at CDMOs and external laboratories.
- Support GMP quality systems (deviations, investigations, CAPAs, change controls, regulatory submissions, facility inspections).
- Collaborate to support CMC development, clinical supply, commercialization, and lifecycle management.
- Author/review technical documents and regulatory content (INDs, IMPDs, NDAs).
- Maintain knowledge of US/EU GMP, ICH guidelines, and regulatory expectations.
- Review scope, timelines, and deliverables to meet contractual, quality, and program objectives.
Education/Experience Requirements:
- B.S. in chemistry/biochemistry/pharmaceutical science/chemical engineering or related life sciences (M.S./Ph.D preferred).
- 8+ years relevant experience emphasizing late-phase development, scale-up, and commercialization.
- Expert knowledge of small molecule API process development/characterization, PPQ, and commercialization for solid oral formulations.
- Experience overseeing CDMOs and contract testing labs (preferably global).
- Broad knowledge of phase-appropriate cGMP and US/EU/ICH guidelines.
- Experience preparing/reviewing CMC sections of IND/IMPD/NDA filings.
Additional Skills/Experience:
- Strong communication, organizational, decision-making, collaboration, and attention to detail.
- Six Sigma/statistics knowledge plus.
- Travel 10–20% domestically/internationally.
- Ability to perform face-to-face/onsite work in San Diego; role not 100% remote.
Total Rewards Offerings (Benefits):
- Premium health, financial, work-life/well-being offerings; wellness and employee support programs; life insurance; disability; retirement plans with employer match; generous paid time off.
Application Instructions:
- Travere will accept applications on an ongoing basis until a candidate is selected for the position.