Director, Small Molecule CMC Operations (Remote)

Travere Therapeutics; New York (NY); Hybrid; USD 150,000 - 195,000; Full time

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. This role collaborates across Quality, Regulatory Affairs, Clinical and Supply Chain to align on risk and milestones for small molecule drug products within late-stage development.

You will lead technical reviews, ensure process validation, and support INDs/NDAs while advancing commercial readiness in a global

Qualifications

• B.S. in chemistry, biochemistry, pharmaceutical science, chemical engineering or related Life Sciences discipline required; M.S./Ph.D. preferred.

Responsibilities

• Provide technical oversight of API production, scale up, process characterization and PPQ for small molecule solid oral drugs.
• Review and approve manufacturing-related documentation including change notifications, batch records, process development, tech transfer and validation reports.
• Verify qualification and validation status at CDMOs and external labs.
• Support GMP quality management systems including deviations, investigations, CAPAs, change controls and regulatory submissions.
• Collaborate with internal and external teams to support CMC development, clinical supply, commercialization and lifecycle management.
• Prepare and review CMC sections of regulatory filings (INDs, IMPDs, NDAs).
• Maintain knowledge of US/EU GMP requirements, ICH guidelines, and regulatory expectations.

Skills

Project management

Cross-functional collaboration

Strong communication

Team player

Interpersonal skills

Written communication

Six Sigma knowledge

Attention to detail

Education

B.S. in chemistry/biochemistry/pharmaceutical science/chemical engineering

M.S./Ph.D. 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. This role collaborates across Quality, Regulatory Affairs, Clinical and Supply Chain to align on risk and milestones for small molecule drug products within late-stage development.

You will lead technical reviews, ensure process validation, and support INDs/NDAs while advancing commercial readiness in a global