Associate Director, Small Molecule CMC Operations - Remote

Travere Therapeutics; Des Moines (IA); On-site; USD 150,000 - 195,000; Full time

Benefits offered by this job

Premium health benefits

Retirement plans with employer match

Generous paid time off

Job summary

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

You will lead process development, characterization, PPQ activities, and regulatory submissions (INDs, IMPDs, NDAs), ensuring cGMP compliance and timely delivery across global

Qualifications

• 8+ years of relevant experience in late-phase clinical development, scale-up, and commercialization.

Responsibilities

• Provide technical oversight of API production, scale-up, and PPQ for small molecule drugs.
• Review/manufacturing docs: batch records, change controls, tech transfer, validation reports.

Skills

Small molecule API development

CDMO management

Process characterization

PPQ

Regulatory submissions

GMP knowledge

Cross-functional collaboration

Risk management

Education

B.S. in chemistry/biochemistry/pharma

M.S./Ph.D. preferred

Job description

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

You will lead process development, characterization, PPQ activities, and regulatory submissions (INDs, IMPDs, NDAs), ensuring cGMP compliance and timely delivery across global