Director, Technical Operations
Travere Therapeutics
June 25, 2026
Remote friendly (United States)
United States
Operations
Position Summary:
The Director, Technical Operations (Small Molecule CMC) provides technical oversight for small molecule API development and manufacturing at Travere CDMOs, partnering across Quality, Regulatory Affairs, Clinical, and Supply Chain to support product development, clinical manufacturing, launch planning, logistics, and lifecycle management.
Responsibilities:
- Oversee API production, scale-up, process characterization, and PPQ for small-molecule solid oral drug products.
- 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 labs.
- Support GMP quality systems (deviations, investigations, CAPAs, change controls, regulatory submissions, facility inspections).
- Collaborate with project 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, ICH guidelines, and related regulatory expectations.
- Review scope, timelines, and deliverables to ensure CDMO obligations and program objectives are met.
Education/Experience Requirements:
- Bachelor’s in Life Sciences/Chemistry/Pharmaceutical Sciences/Biochemistry/Chemical Engineering or related field (or equivalent).
- MS/PhD preferred.
- 10+ years in small-molecule API development/manufacturing (late-stage clinical development, scale-up, commercialization).
- Extensive CMC experience across process development → characterization → PPQ → commercialization → tech transfer for solid oral dosage forms.
- Experience managing global CDMOs/third-party manufacturers/testing labs.
- Broad knowledge of phase-appropriate cGMP and US/EU/ICH guidelines.
- Ability to prepare/review CMC sections of INDs/IMPDs/NDAs.
Additional Skills/Experience:
- Strong project planning and risk mitigation.
- Flexibility to adapt plans/strategies.
- Excellent communication, interpersonal/organizational skills; strong decision-making and attention to detail.
- Six Sigma/statistical knowledge is a plus.
- Travel 10–20%.
- Must be able to perform face-to-face work with colleagues and/or onsite in San Diego; not 100% remote.
Benefits:
- Premium health, financial, work-life and well-being offerings (including for dependents), wellness/support programs, life insurance, disability, retirement with employer match, and generous paid time off.
Compensation:
- Target base pay range: $189,000.00–$246,000.00.
Application Instructions:
- Travere will accept applications on an ongoing basis until a candidate is selected.
The Director, Technical Operations (Small Molecule CMC) provides technical oversight for small molecule API development and manufacturing at Travere CDMOs, partnering across Quality, Regulatory Affairs, Clinical, and Supply Chain to support product development, clinical manufacturing, launch planning, logistics, and lifecycle management.
Responsibilities:
- Oversee API production, scale-up, process characterization, and PPQ for small-molecule solid oral drug products.
- 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 labs.
- Support GMP quality systems (deviations, investigations, CAPAs, change controls, regulatory submissions, facility inspections).
- Collaborate with project 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, ICH guidelines, and related regulatory expectations.
- Review scope, timelines, and deliverables to ensure CDMO obligations and program objectives are met.
Education/Experience Requirements:
- Bachelor’s in Life Sciences/Chemistry/Pharmaceutical Sciences/Biochemistry/Chemical Engineering or related field (or equivalent).
- MS/PhD preferred.
- 10+ years in small-molecule API development/manufacturing (late-stage clinical development, scale-up, commercialization).
- Extensive CMC experience across process development → characterization → PPQ → commercialization → tech transfer for solid oral dosage forms.
- Experience managing global CDMOs/third-party manufacturers/testing labs.
- Broad knowledge of phase-appropriate cGMP and US/EU/ICH guidelines.
- Ability to prepare/review CMC sections of INDs/IMPDs/NDAs.
Additional Skills/Experience:
- Strong project planning and risk mitigation.
- Flexibility to adapt plans/strategies.
- Excellent communication, interpersonal/organizational skills; strong decision-making and attention to detail.
- Six Sigma/statistical knowledge is a plus.
- Travel 10–20%.
- Must be able to perform face-to-face work with colleagues and/or onsite in San Diego; not 100% remote.
Benefits:
- Premium health, financial, work-life and well-being offerings (including for dependents), wellness/support programs, life insurance, disability, retirement with employer match, and generous paid time off.
Compensation:
- Target base pay range: $189,000.00–$246,000.00.
Application Instructions:
- Travere will accept applications on an ongoing basis until a candidate is selected.