Associate Director, Small Molecule CMC Operations (Remote)

Travere Therapeutics; Salt Lake City (UT); On-site; USD 150,000 - 195,000; Full time

Benefits offered by this job

Premium health insurance

Retirement plan with employer match

Generous paid time off

Job summary

Travere Therapeutics seeks an Associate Director, Technical Operations (Small Molecule CMC) to oversee API development and manufacturing at Travere CDMOs. This role partners with Quality, Regulatory Affairs, Clinical, and Supply Chain to meet program milestones and advance a late-stage asset to commercial readiness.

The ideal candidate has 8+ years in late-stage development, strong CDMO oversight experience, and in-depth knowledge of cGMP, ICH guidelines, and regulatory filings (INDs, NDAs,

Qualifications

• BS in chemistry or related life sciences; MS/PhD preferred.
• 8+ years in late-phase clinical development and scale-up.
• Experience managing CDMOs and external labs.
• Strong knowledge of US/EU ICH guidelines and cGMP.

Responsibilities

• Provide technical oversight of small molecule API production, scale up, and PPQ for solid oral drug products.
• Review and approve manufacturing documentation (change notifications, batch records, process development, tech transfer).
• Verify qualification/validation status of processes at CDMOs and external labs.
• Support GMP quality systems (deviations, investigations, CAPAs, change controls, regulatory submissions, inspections).
• Collaborate with internal/external teams to support CMC development, clinical supply, and lifecycle management.

Skills

Process development

PPQ

CDMO oversight

Regulatory submissions (CMC)

Cross-functional collaboration

Education

B.S. in Chemistry/Biochemistry/Pharmaceutical Science

M.S. or Ph.D. preferred

Job description

Travere Therapeutics seeks an Associate Director, Technical Operations (Small Molecule CMC) to oversee API development and manufacturing at Travere CDMOs. This role partners with Quality, Regulatory Affairs, Clinical, and Supply Chain to meet program milestones and advance a late-stage asset to commercial readiness.

The ideal candidate has 8+ years in late-stage development, strong CDMO oversight experience, and in-depth knowledge of cGMP, ICH guidelines, and regulatory filings (INDs, NDAs,