Remote-Ready Associate Director, Small Molecule CMC Ops

Travere Therapeutics; San Diego (CA); Hybrid; USD 150,000 - 195,000; Full time

Benefits offered by this job

Premium health benefits

Retirement plans with employer match

Generous paid time off

Well-being programs

Job summary

Travere Therapeutics in San Diego, CA, seeks an Associate Director, Technical Operations (Small Molecule CMC) to provide technical oversight of API development and manufacturing across CDMOs. This role partners with Quality, Regulatory Affairs, Clinical, and Supply Chain to ensure alignment and program milestones are met.

The ideal candidate has 8+ years in late‑phase development, expertise in process development, PPQ, and commercialization of small molecule APIs, and a track record managing

Qualifications

• 8+ years of relevant experience with emphasis on late‑phase clinical development, scale‑up, and commercialization.
• Expert knowledge in process development, characterization studies, PPQ, and commercialization of small molecule APIs for solid oral dosage forms.
• Experience managing and providing technical oversight of CDMOs and contract testing labs across global sites.
• Familiarity with US, EU GMP requirements and ICH guidelines.
• Ability to prepare and review CMC sections of INDs/IMPDs/NDAs.

Responsibilities

• Provide technical oversight of API production, scale up, process characterization, and PPQ for a small molecule, solid oral drug product manufactured at Travere CDMOs.
• Review and approve manufacturing documentation, including 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 other external laboratories.
• Provide technical support for GMP quality management systems, including deviations, investigations, CAPAs, change controls, regulatory submissions, and facility inspections.
• Collaborate with internal and external project teams to support CMC development, clinical supply, commercialization, and lifecycle management of small molecule drug products.
• Author and review technical documents and regulatory submission content, including INDs, IMPDs, and NDAs.
• Maintain up‑to‑date knowledge of US and EU GMP requirements, ICH guidelines, and other regulatory expectations.

Education

B.S. degree in chemistry/biochemistry/pharmaceutical science/chemical engineering or related Life Sciences

M.S. or Ph.D. degree preferred

Tools

Six Sigma

Job description

Travere Therapeutics in San Diego, CA, seeks an Associate Director, Technical Operations (Small Molecule CMC) to provide technical oversight of API development and manufacturing across CDMOs. This role partners with Quality, Regulatory Affairs, Clinical, and Supply Chain to ensure alignment and program milestones are met.

The ideal candidate has 8+ years in late‑phase development, expertise in process development, PPQ, and commercialization of small molecule APIs, and a track record managing