Associate Director, Small Molecule CMC Operations

Travere Therapeutics; Wichita (KS); On-site; USD 150,000 - 195,000; Full time

Benefits offered by this job

Premium health

Well-being programs

Employer 401(k) match

Job summary

Travere Therapeutics in San Diego, CA is seeking an Associate Director, Technical Operations (Small Molecule CMC) to provide technical oversight of API development and manufacturing at Travere CDMOs. This senior role collaborates with Quality, Regulatory Affairs, Clinical, and Supply Chain to meet milestones.

The ideal candidate has 8+ years in late-phase development, strong knowledge of cGMP, process development, and CDMO oversight.

Qualifications

• 8+ years of relevant experience in late-phase clinical development, scale-up, and commercialization.
• Expert knowledge in process development, characterization studies, PPQ, and commercialization of small molecule APIs.

Responsibilities

• Provide technical oversight of API production, scale up, process characterization, and PPQ for a small molecule drug product.
• Review and approve manufacturing documentation (batch records, change controls, validations).
• Ensure CDMO quality and regulatory compliance across global sites.

Skills

Project leadership

Cross-functional collaboration

Communication skills

Education

B.S. in life sciences

M.S./Ph.D. preferred

Job description

Travere Therapeutics in San Diego, CA is seeking an Associate Director, Technical Operations (Small Molecule CMC) to provide technical oversight of API development and manufacturing at Travere CDMOs. This senior role collaborates with Quality, Regulatory Affairs, Clinical, and Supply Chain to meet milestones.

The ideal candidate has 8+ years in late-phase development, strong knowledge of cGMP, process development, and CDMO oversight.