CMC Strategy & Tech Ops Director - Remote

Travere Therapeutics; Oklahoma City (OK); Hybrid; USD 150,000 - 195,000; Full time

Benefits offered by this job

Health benefits

Retirement plans with employer match

Paid time off

Stock options

Job summary

Travere Therapeutics is seeking a senior CMC-Operations leader to manage the development and execution of the CMC strategy for multiple small molecules in development. The role oversees external manufacturing partners and collaborates with Quality, Regulatory, Clinical, Supply Chain and Program Management to mitigate CMC risks and achieve milestones.

The successful candidate will lead CMOs for development and manufacturing, ensure regulatory readiness, and provide mentorship to teams across

Qualifications

• Bachelor's degree in Process or Chemical Engineering, Life Sciences, or related field.
• 8+ years of progressive cGMP-related CMC drug development or manufacturing experience.
• Experience leading CMC teams across multiple areas and molecules.

Responsibilities

• Provide strategic leadership for technology transfer, scale-up, validation, and cGMP manufacturing across clinical and commercial products.
• Lead selection/qualification of CMOs and partners, ensuring scope, quality, timelines and budget.
• Oversee chemical development of new drug candidates and review regulatory filings and change controls.
• Provide technical oversight of CMOs for API and finished dosage forms; support inspections and regulatory expectations.
• Mentor cross-functional project teams and contribute to regulatory submissions.

Skills

CMC Leadership

Oral Solid Dosage

Process Validation

Technology Transfer

Regulatory Support

Communication Skills

Team Collaboration

Education

Bachelors in Engineering or Life Sciences

Job description

Travere Therapeutics is seeking a senior CMC-Operations leader to manage the development and execution of the CMC strategy for multiple small molecules in development. The role oversees external manufacturing partners and collaborates with Quality, Regulatory, Clinical, Supply Chain and Program Management to mitigate CMC risks and achieve milestones.

The successful candidate will lead CMOs for development and manufacturing, ensure regulatory readiness, and provide mentorship to teams across