Senior Leader, Small Molecule CMC Operations (Remote)

Travere Therapeutics; Providence (RI); Hybrid; USD 150,000 - 195,000; Full time

Benefits offered by this job

Premium health

Financial wellness

Work-life balance

Retirement plan

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 at Travere CDMOs. The role partners with Quality, Regulatory, Clinical and Supply Chain to advance late-stage assets to commercial readiness.

The successful candidate will bring 8+ years in small molecule API development, with experience in process characterization, PPQ, regulatory filings (INDs/NDAs), and managing

Qualifications

• Must have 8+ years of experience in late-phase clinical development and commercialization.
• Expert knowledge in process development, PPQ, and API commercialization for small molecules.
• Experience managing CDMOs across global sites and regulatory submissions.

Responsibilities

• Provide technical oversight of API production, scale-up, and PPQ for small molecule products.
• Review manufacturing docs, batch records, and validation reports for CDMOs.
• Support GMP quality systems, deviations, CAPAs, and regulatory submissions.
• Collaborate with internal/external teams to enable regulatory filings (INDs/NDAs).
• Maintain knowledge of US/EU GMP and ICH guidelines; ensure CDMO obligations are met.

Skills

CMC development

CDMO oversight

Project management

Risk mitigation

Cross-functional collaboration

Travel flexibility

Education

Bachelor's degree in Life Sciences

MS/PhD preferred

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 at Travere CDMOs. The role partners with Quality, Regulatory, Clinical and Supply Chain to advance late-stage assets to commercial readiness.

The successful candidate will bring 8+ years in small molecule API development, with experience in process characterization, PPQ, regulatory filings (INDs/NDAs), and managing