Director, Technical Operations
Travere Therapeutics
August 07, 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, serving as a key technical contact and supporting 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 process suitability, qualification, and validation status at CDMOs and external labs.
- Support GMP quality systems (deviations, investigations, CAPAs, change controls, regulatory submissions, inspections).
- Collaborate across internal/external teams for CMC development and lifecycle management.
- Author/review technical documents and regulatory content (INDs, IMPDs, NDAs).
- Maintain expertise in US/EU GMP and ICH requirements.
- Ensure CDMO scope, timelines, and deliverables meet contractual and quality objectives.
Education/Experience Requirements:
- Bachelor’s degree in Life Sciences/Chemistry/Pharmaceutical Sciences/Biochemistry/Chemical Engineering (or related); MS/PhD preferred.
- 10+ years relevant experience in small-molecule API development/manufacturing (late-stage clinical development, scale-up, commercialization).
- Expert CMC experience from development through characterization, PPQ, commercialization, and tech transfer for solid oral dosage forms.
- Experience managing global CDMOs/third-party manufacturers/testing labs; strong cGMP (US/EU/ICH).
Additional Skills/Experience:
- Demonstrated ability to prepare/review CMC sections of regulatory filings.
- Strong project/risk mitigation, flexibility, communication, decision-making, teamwork; Six Sigma/statistical knowledge a plus.
- Travel 10–20%; on-site/face-to-face essential in San Diego; not fully remote.
Benefits:
- Premium health, financial, work-life/well-being offerings; life insurance, disability, retirement match, and generous paid time off.
Application Instructions:
- Apply 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, serving as a key technical contact and supporting 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 process suitability, qualification, and validation status at CDMOs and external labs.
- Support GMP quality systems (deviations, investigations, CAPAs, change controls, regulatory submissions, inspections).
- Collaborate across internal/external teams for CMC development and lifecycle management.
- Author/review technical documents and regulatory content (INDs, IMPDs, NDAs).
- Maintain expertise in US/EU GMP and ICH requirements.
- Ensure CDMO scope, timelines, and deliverables meet contractual and quality objectives.
Education/Experience Requirements:
- Bachelor’s degree in Life Sciences/Chemistry/Pharmaceutical Sciences/Biochemistry/Chemical Engineering (or related); MS/PhD preferred.
- 10+ years relevant experience in small-molecule API development/manufacturing (late-stage clinical development, scale-up, commercialization).
- Expert CMC experience from development through characterization, PPQ, commercialization, and tech transfer for solid oral dosage forms.
- Experience managing global CDMOs/third-party manufacturers/testing labs; strong cGMP (US/EU/ICH).
Additional Skills/Experience:
- Demonstrated ability to prepare/review CMC sections of regulatory filings.
- Strong project/risk mitigation, flexibility, communication, decision-making, teamwork; Six Sigma/statistical knowledge a plus.
- Travel 10–20%; on-site/face-to-face essential in San Diego; not fully remote.
Benefits:
- Premium health, financial, work-life/well-being offerings; life insurance, disability, retirement match, and generous paid time off.
Application Instructions:
- Apply on an ongoing basis until a candidate is selected.