Senior Tech Ops Lead, Small Molecule CMC (Remote)

Travere Therapeutics; Atlanta (GA); Hybrid; USD 150,000 - 195,000; Full time

Benefits offered by this job

Premium health benefits

Job summary

Travere Therapeutics in San Diego, CA, seeks an Associate Director of Technical Operations (Small Molecule CMC) to provide technical oversight of API development and manufacturing at Travere CDMOs. You will collaborate with Quality, Regulatory Affairs, Clinical, and Supply Chain to meet program milestones for late-stage development and commercial readiness.

The role requires 8+ years in small molecule development, strong cGMP knowledge, and proven oversight of CDMOs and testing labs across

Qualifications

• Experience in late-stage clinical development and commercialization.
• Ability to manage and oversee CDMOs and contract testing labs globally.
• Strong knowledge of cGMP, ICH guidelines, and regulatory expectations for pharma development.

Responsibilities

• Provide technical oversight of API production, scale up, process characterization, and PPQ for small molecule solid oral products.
• Review and approve manufacturing docs: change notifications, batch records, process development, tech transfer, validation reports.
• Verify suitability of CDMO processes and external labs; ensure qualification/validation status.
• Support GMP quality management activities: deviations, investigations, CAPAs, change controls, regulatory submissions, inspections.
• Collaborate with internal/external teams for CMC development, clinical supply, and lifecycle management.
• Prepare/review CMC sections of INDs, IMPDs, and NDAs.

Skills

Small molecule API development

CDMO oversight

Process development

Regulatory submissions (INDs/NDAs/IMPD

QA/QC collaboration

Education

BS in chemistry/related Life Sciences

MS/PhD preferred

Job description

Travere Therapeutics in San Diego, CA, seeks an Associate Director of Technical Operations (Small Molecule CMC) to provide technical oversight of API development and manufacturing at Travere CDMOs. You will collaborate with Quality, Regulatory Affairs, Clinical, and Supply Chain to meet program milestones for late-stage development and commercial readiness.

The role requires 8+ years in small molecule development, strong cGMP knowledge, and proven oversight of CDMOs and testing labs across