Director, Technical Operations
Travere Therapeutics
August 07, 2026
Remote friendly (San Diego Metropolitan Area)
United States
Operations
Position Summary:
The Director, Technical Operations (Small Molecule CMC) provides technical oversight for small molecule API development and manufacturing activities conducted at CDMOs. Serves as a key technical point of contact within Technical Operations (CMC) supporting product development, clinical manufacturing, commercial launch planning, logistics, and lifecycle management.
Responsibilities:
- Provide technical oversight of API production, scale up, process characterization, and PPQ for small molecule solid oral drug products manufactured at CDMOs.
- Review/approve manufacturing documentation: change notifications, batch records, process development, tech transfer, process characterization, and validation protocols/reports.
- Verify suitability, qualification, and validation status of processes at CDMOs and external labs.
- Support GMP quality management systems (deviations, investigations, CAPAs, change controls, regulatory submissions, facility inspections).
- Collaborate on CMC development, clinical supply, commercialization, and lifecycle management.
- Author/review technical documents and regulatory submission content (INDs, IMPDs, NDAs).
- Maintain knowledge of US/EU GMP requirements, ICH guidelines, and other regulatory expectations.
- Review project scope/timelines/deliverables to ensure CDMO contractual and quality/program alignment.
Education/Experience Requirements:
- BS in Life Sciences/Chemistry/Pharm Sciences/Biochemistry/Chemical Engineering or related (equivalent experience considered).
- MS/PhD preferred.
- 10+ years in small molecule API development/manufacturing, late-phase clinical development, scale-up, commercialization.
- Expert CMC knowledge from process development through commercialization and tech transfers.
- Experience managing global CDMOs, third-party manufacturers, and testing labs.
- Phase-appropriate cGMP knowledge; US/EU/ICH familiarity.
- Ability to prepare/review CMC sections of regulatory filings (INDs/IMPs/NDAs).
Additional Skills/Experience:
- Values-driven (Courage, Community Spirit, Patient Focus, Teamwork).
- Track record managing complex plans/timelines/budgets and risk mitigation.
- Flexibility to adapt to changing project plans.
- Strong communication, decision-making, collaboration, and attention to detail.
- Six Sigma/statistical knowledge plus.
- Travel 10–20% domestically/internationally.
Benefits:
- Premium health, financial, work-life/well-being offerings; wellness support; life insurance; disability; retirement with match; generous paid time off.
Compensation:
- Target base pay range: $189,000.00–$246,000.00.
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 activities conducted at CDMOs. Serves as a key technical point of contact within Technical Operations (CMC) supporting product development, clinical manufacturing, commercial launch planning, logistics, and lifecycle management.
Responsibilities:
- Provide technical oversight of API production, scale up, process characterization, and PPQ for small molecule solid oral drug products manufactured at CDMOs.
- Review/approve manufacturing documentation: change notifications, batch records, process development, tech transfer, process characterization, and validation protocols/reports.
- Verify suitability, qualification, and validation status of processes at CDMOs and external labs.
- Support GMP quality management systems (deviations, investigations, CAPAs, change controls, regulatory submissions, facility inspections).
- Collaborate on CMC development, clinical supply, commercialization, and lifecycle management.
- Author/review technical documents and regulatory submission content (INDs, IMPDs, NDAs).
- Maintain knowledge of US/EU GMP requirements, ICH guidelines, and other regulatory expectations.
- Review project scope/timelines/deliverables to ensure CDMO contractual and quality/program alignment.
Education/Experience Requirements:
- BS in Life Sciences/Chemistry/Pharm Sciences/Biochemistry/Chemical Engineering or related (equivalent experience considered).
- MS/PhD preferred.
- 10+ years in small molecule API development/manufacturing, late-phase clinical development, scale-up, commercialization.
- Expert CMC knowledge from process development through commercialization and tech transfers.
- Experience managing global CDMOs, third-party manufacturers, and testing labs.
- Phase-appropriate cGMP knowledge; US/EU/ICH familiarity.
- Ability to prepare/review CMC sections of regulatory filings (INDs/IMPs/NDAs).
Additional Skills/Experience:
- Values-driven (Courage, Community Spirit, Patient Focus, Teamwork).
- Track record managing complex plans/timelines/budgets and risk mitigation.
- Flexibility to adapt to changing project plans.
- Strong communication, decision-making, collaboration, and attention to detail.
- Six Sigma/statistical knowledge plus.
- Travel 10–20% domestically/internationally.
Benefits:
- Premium health, financial, work-life/well-being offerings; wellness support; life insurance; disability; retirement with match; generous paid time off.
Compensation:
- Target base pay range: $189,000.00–$246,000.00.
Application Instructions:
- Apply on an ongoing basis until a candidate is selected.