Associate Director, Small Molecule CMC Operations (Remote)

Travere Therapeutics; Oklahoma City (OK); Hybrid; USD 150,000 - 195,000; Full time

Benefits offered by this job

Premium health benefits

Competitive compensation

Job summary

Travere Therapeutics, based in San Diego, seeks an Associate Director, Technical Operations (Small Molecule CMC) to provide technical oversight of API development and manufacturing at Travere CDMOs.

You will collaborate with Quality, Regulatory Affairs, Clinical, and Supply Chain to advance late-stage assets to commercial readiness, ensuring phase-appropriate cGMP and regulatory alignment across US and EU requirements.

Qualifications

• Minimum 8+ years of relevant experience in late-phase clinical development, scale-up, and commercialization.
• Expert knowledge in process development, characterization studies, PPQ, and small molecule APIs for solid oral dosage forms.
• Experience managing CDMOs and contract testing labs across global sites.
• Familiarity with US, EU, and ICH cGMP guidelines and regulatory filing support.

Responsibilities

• Provide technical oversight of API production, scale-up, and PPQ for small molecule solid oral products.
• Review and approve manufacturing documentation, change controls, and validation reports.
• Verify CDMO qualifications and validation status of processes and testing.
• Support GMP quality systems, deviations, CAPAs, and regulatory submissions.
• Collaborate with cross-functional teams to enable development, clinical supply, and lifecycle management.

Skills

CMC development

CDMO oversight

Regulatory readiness

Project management

GMP knowledge

Education

B.S. in chemistry/biochemistry/pharma

M.S. or Ph.D. preferred

Job description

Travere Therapeutics, based in San Diego, seeks an Associate Director, Technical Operations (Small Molecule CMC) to provide technical oversight of API development and manufacturing at Travere CDMOs.

You will collaborate with Quality, Regulatory Affairs, Clinical, and Supply Chain to advance late-stage assets to commercial readiness, ensuring phase-appropriate cGMP and regulatory alignment across US and EU requirements.