Director, Small Molecule CMC Operations - Remote

Travere Therapeutics; San Diego (CA); Hybrid; USD 189,000 - 246,000; Full time

Benefits offered by this job

Premium health benefits

Stock options

Job summary

Travere Therapeutics, a biopharma company focused on rare diseases, seeks a Director of Technical Operations (Small Molecule CMC) to provide technical oversight for API development and manufacturing at Travere CDMOs. You will collaborate across Quality, Regulatory Affairs, Clinical, and Supply Chain to ensure milestones are met.

This role requires 10+ years in small molecule API development, strong cGMP knowledge, and experience managing global CDMOs.

Qualifications

• Bachelor’s degree required in life sciences or related field.
• 10+ years in small molecule API development and manufacturing.
• Experience with late‑phase development and tech transfer.
• Global CDMO management experience.
• Knowledge of US/EU ICH guidelines and cGMP.

Responsibilities

• Provide technical oversight of API production and PPQ at Travere CDMOs.
• Review manufacturing documentation and change controls.
• Verify qualification of CDMOs and external labs.
• Support GMP quality management systems, deviations, CAPAs.
• Collaborate with teams for CMC development and lifecycle management.
• Prepare regulatory submission content (INDs, IMPDs, NDAs).
• Maintain knowledge of US/EU GMP and ICH guidelines.
• Ensure CDMO work meets contractual obligations.

Skills

CMC leadership

Regulatory submissions

Project management

Cross-functional collaboration

Communication

Education

Bachelor’s degree in Life Sciences or related field

MS or PhD preferred

Job description

Travere Therapeutics, a biopharma company focused on rare diseases, seeks a Director of Technical Operations (Small Molecule CMC) to provide technical oversight for API development and manufacturing at Travere CDMOs. You will collaborate across Quality, Regulatory Affairs, Clinical, and Supply Chain to ensure milestones are met.

This role requires 10+ years in small molecule API development, strong cGMP knowledge, and experience managing global CDMOs.