CMC Strategy Lead - Technical Operations (Remote)

Travere Therapeutics; Detroit (MI); Hybrid; USD 150,000 - 195,000; Full time

Job summary

Travere Therapeutics in San Diego is seeking a Senior Director, Technical Operations to lead the CMC strategy for a diverse portfolio of small molecules in development, ensuring test article and study drug are developed and manufactured on time, within budget and scope.

This role collaborates with Quality, Regulatory Affairs, Clinical, Supply Chain, and Program Management to identify and mitigate CMC risks and achieve milestones.

Qualifications

• Bachelor's degree in a relevant discipline with 8+ years cGMP CMC experience.
• Experience leading CMC programs for small molecules, peptides, or biologics.
• Proven leadership in external manufacturing, CMOs, and regulatory interactions.

Responsibilities

• Provide strategic leadership for technology transfer, scale-up, validation, and manufacturing activities.
• Lead selection and governance of CMOs and external partners to meet scope, quality, and budgets.
• Oversee chemical development of new drug candidates.
• Review regulatory filings, specs, change controls, and Master Batch Records.
• Provide technical oversight of CMOs for APIs and finished dosage forms; support inspections.
• Provide technical leadership and mentorship to cross-functional teams.
• Author or edit CMC sections of regulatory submissions as required.
• Additional duties as needed.

Skills

Leadership

CMC Leadership

Process validation

Technology transfer

Regulatory filings

Education

Bachelor's degree in engineering or life sciences

Job description

Travere Therapeutics in San Diego is seeking a Senior Director, Technical Operations to lead the CMC strategy for a diverse portfolio of small molecules in development, ensuring test article and study drug are developed and manufactured on time, within budget and scope.

This role collaborates with Quality, Regulatory Affairs, Clinical, Supply Chain, and Program Management to identify and mitigate CMC risks and achieve milestones.