Director, Small Molecule CMC & Tech Ops

Travere Therapeutics; Denver (CO); Hybrid; USD 189,000 - 246,000; Full time

Benefits offered by this job

Premium health benefits

Financial wellness programs

Paid time off

Retirement plans with employer match

Job summary

Travere Therapeutics is seeking a Director of Technical Operations to provide oversight for small molecule API development and manufacturing. The selected candidate will work closely with Quality, Regulatory Affairs, Clinical, and Supply Chain to drive project success.

Key responsibilities include approving manufacturing documentation, ensuring regulatory compliance, and collaborating with cross-functional teams. A minimum of 10 years’ experience in small molecule manufacturing is required. The role is based in the United States, with certain remote working options.

Qualifications

• 10+ years of relevant experience in small molecule API development and manufacturing.
• Expert knowledge advancing small molecule APIs from process development to commercialization.
• Extensive experience managing global CDMOs and compliance with GMP.

Responsibilities

• Provide technical oversight of API production and process qualification.
• Review and approve manufacturing-related documentation and change notifications.
• Collaborate with internal teams to support CMC development and commercialization.

Skills

Technical oversight

API development

GMP compliance

Cross-functional collaboration

Regulatory submissions

Education

Bachelor's degree in Life Sciences or related discipline

M.S. or Ph.D. preferred

Job description

Travere Therapeutics is seeking a Director of Technical Operations to provide oversight for small molecule API development and manufacturing. The selected candidate will work closely with Quality, Regulatory Affairs, Clinical, and Supply Chain to drive project success.

Key responsibilities include approving manufacturing documentation, ensuring regulatory compliance, and collaborating with cross-functional teams. A minimum of 10 years’ experience in small molecule manufacturing is required. The role is based in the United States, with certain remote working options.