Associate Director, Small Molecule CMC Operations

Travere Therapeutics; Detroit (MI); On-site; USD 150,000 - 195,000; Full time

Benefits offered by this job

Health benefits

Retirement plan with employer match

Generous paid time off

Life insurance

Disability insurance

Job summary

Travere Therapeutics in San Diego is seeking an Associate Director, Technical Operations (Small Molecule CMC) to provide technical oversight for API development and manufacturing at Travere CDMOs, enabling late-stage development to commercial readiness.

The role partners with Quality, Regulatory, Clinical, and Supply Chain to ensure alignment, risk management, and achievement of program milestones, with experience in small molecule APIs.

Qualifications

• 8+ years in late-stage clinical development and scale-up.
• Expert knowledge in process development, PPQ, and commercialization of small molecule APIs.
• Experience managing CDMOs and contract testing labs globally.
• Knowledge of US/EU ICH guidelines and cGMP requirements.

Responsibilities

• Provide technical oversight of API production, scale up, PPQ for a small molecule solid oral drug product.
• Review and approve manufacturing documentation, batch records, process development, tech transfer, validation protocols/reports.
• Verify qualification and validation status of processes at CDMOs and external labs.
• Support GMP quality systems, deviations, investigations, CAPAs, changes, regulatory submissions.
• Collaborate with internal/external teams for CMC development, clinical supply, lifecycle management.
• Prepare/review CMC sections for INDs, IMPDs, and NDAs.

Skills

Small molecule CMC oversight

Process development

Regulatory submissions

GMP/compliance

CDMO oversight

Cross-functional collaboration

Education

BS in chemistry/biochemistry/pharmaceutical sciences

MS or PhD preferred

Tools

IND/IMPD/NDAs

cGMP guidelines

Job description

Travere Therapeutics in San Diego is seeking an Associate Director, Technical Operations (Small Molecule CMC) to provide technical oversight for API development and manufacturing at Travere CDMOs, enabling late-stage development to commercial readiness.

The role partners with Quality, Regulatory, Clinical, and Supply Chain to ensure alignment, risk management, and achievement of program milestones, with experience in small molecule APIs.