Senior Leader, Small Molecule CMC Operations (Remote)

Travere Therapeutics; United States; Hybrid; USD 150,000 - 195,000; Full time

Benefits offered by this job

Job summary

Travere Therapeutics seeks an Associate Director of Technical Operations (Small Molecule CMC) to oversee API development and manufacturing at Travere CDMOs, enabling clinical and commercial readiness. You will collaborate with Quality, Regulatory Affairs, Clinical, and Supply Chain to ensure alignment with program milestones.

The role requires extensive experience in small molecule development, PPQ, and scale-up, with global CDMO oversight and hands-on regulatory preparation for INDs/NDAs.

Qualifications

• 8+ years of late-stage clinical development and commercialization.

Responsibilities

• Provide technical oversight of API production, scale-up, PPQ for a small molecule API at Travere CDMOs.

Skills

Small molecule API

CDMO oversight

Process development

Regulatory submissions

PPQ

Tech transfer

Cross-functional collaboration

Education

B.S. in Chemistry or related Life Sciences

M.S. or Ph.D. preferred

Job description

Travere Therapeutics seeks an Associate Director of Technical Operations (Small Molecule CMC) to oversee API development and manufacturing at Travere CDMOs, enabling clinical and commercial readiness. You will collaborate with Quality, Regulatory Affairs, Clinical, and Supply Chain to ensure alignment with program milestones.

The role requires extensive experience in small molecule development, PPQ, and scale-up, with global CDMO oversight and hands-on regulatory preparation for INDs/NDAs.