Associate Director, Small Molecule CMC Operations - Remote

Travere Therapeutics; Columbus (OH); Hybrid; USD 150,000 - 195,000; Full time

Job summary

Travere Therapeutics in San Diego, CA is seeking an Associate Director, Technical Operations (Small Molecule CMC) to provide technical oversight of API development and manufacturing with Travere CDMOs. This role partners with Quality, Regulatory Affairs, Clinical, and Supply Chain to ensure milestone alignment and readiness for late-stage development.

The candidate will have a BS in a life sciences field with 8+ years in late-phase development, PPQ, and CDMO oversight, and will stay current with

Qualifications

• BS degree required; MS/PhD preferred.
• 8+ years in late-phase development, scale-up, and commercialization.
• Experience managing CDMOs/contract labs across global sites.
• Strong knowledge of US/EU GMP and ICH guidelines; CMC regulatory writing experience.

Responsibilities

• Provide technical oversight of API production, scale-up, PPQ for small molecule solid oral products at Travere CDMOs.
• Review/approve manufacturing docs: change notifications, batch records, tech transfer, validation reports.
• Verify qualification/validation status of CDMO processes.
• Support GMP quality management: deviations, investigations, CAPAs, change controls, regulatory submissions, inspections.
• Collaborate with internal/external teams for CMC development, clinical supply, and lifecycle management.
• Author/review regulatory content including INDs, IMPDs, and NDAs.
• Maintain up-to-date knowledge of GMPs and regulatory expectations.
• Review project scope, timelines, and CDMO-delivered deliverables.

Skills

Process development & PPQ

CDMO oversight

cGMP & ICH guidelines

CMC regulatory writing

Education

BS in chemistry/biochemistry/pharma science/chemical engineering or related Life Sciences

Job description

Travere Therapeutics in San Diego, CA is seeking an Associate Director, Technical Operations (Small Molecule CMC) to provide technical oversight of API development and manufacturing with Travere CDMOs. This role partners with Quality, Regulatory Affairs, Clinical, and Supply Chain to ensure milestone alignment and readiness for late-stage development.

The candidate will have a BS in a life sciences field with 8+ years in late-phase development, PPQ, and CDMO oversight, and will stay current with