Associate Director, Small Molecule CMC Operations

Travere Therapeutics; Columbia (SC); Hybrid; USD 150,000 - 195,000; Full time

Benefits offered by this job

Premium health benefits

Financialwell-being programs

Retirement plans with employer match

Generous paid time off

Job summary

Travere Therapeutics is seeking an Associate Director, Technical Operations (Small Molecule CMC) to provide technical oversight for API development and manufacturing at Travere CDMOs in support of late-stage development and commercialization. The role partners with Quality, Regulatory Affairs, Clinical, and Supply Chain to meet program milestones.

The candidate will oversee process development, PPQ, and CDMO qualification, with extensive experience in small molecule APIs for solid oral dosage

Qualifications

• BS in chemistry, biochemistry, pharmaceutical science, chemical engineering, or related Life Sciences.
• 8+ years of relevant experience with emphasis on late-phase clinical development, scale-up, and commercialization.
• Expert knowledge in process development, PPQ, and commercialization of small molecule APIs for solid oral dosage forms.
• Experience managing CDMOs and contract testing labs across global sites.
• Broad knowledge of US, EU, and ICH guidelines for pharmaceutical development.

Responsibilities

• Provide technical oversight of API production, scale-up and PPQ for small molecule solid oral dosage forms.
• Review manufacturing documentation including batch records and validation protocols.
• Ensure CDMO qualification and validation status.
• Support GMP quality systems including deviations, investigations, CAPAs, change controls, and regulatory submissions.
• Collaborate with internal and external project teams for CMC development and lifecycle management.
• Prepare and review regulatory submissions content (INDs, IMPDs, NDAs).
• Maintain up-to-date knowledge of US and EU GMP requirements and regulatory expectations.

Skills

API development

Process characterization

PPQ

CDMO oversight

Regulatory submissions

Cross-functional collaboration

gCMP knowledge

Education

BS in chemistry or Life Sciences

MS/PhD preferred

Job description

Travere Therapeutics is seeking an Associate Director, Technical Operations (Small Molecule CMC) to provide technical oversight for API development and manufacturing at Travere CDMOs in support of late-stage development and commercialization. The role partners with Quality, Regulatory Affairs, Clinical, and Supply Chain to meet program milestones.

The candidate will oversee process development, PPQ, and CDMO qualification, with extensive experience in small molecule APIs for solid oral dosage