Remote CMC Lead, Technical Operations

Travere Therapeutics; Columbia (SC); Hybrid; USD 150,000 - 195,000; Full time

Job summary

Travere Therapeutics in San Diego seeks 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 oversees CMOs, collaborates with Quality, Regulatory, Clinical, and Supply Chain, and mentors cross-functional teams to mitigate CMC risks and achieve milestones in development and commercialization.

Qualifications

• 8+ years of progressive cGMP-related CMC drug development or manufacturing experience.
• Leadership experience in CMC across multiple areas and drug development stages.
• Experience with small molecules, peptides, and biologics of varying complexity.

Responsibilities

• Provide strategic leadership for technology transfer, scale-up, validation, and cGMP manufacturing.
• Oversee selection and governance of CMOs and external partners to meet scope and timelines.
• Direct chemical development of new drug candidates.
• Review regulatory filings, specs, change controls, and master batch records.
• Ensure regulatory inspections and partner audits meet cGMP standards.
• Mentor cross-functional teams and contribute to regulatory submissions.

Skills

CMC Leadership

Tech Transfer

Regulatory Strategy

Education

Bachelor's degree in Chemical Engineering

Tools

cGMP Compliance

CMO Management

Job description

Travere Therapeutics in San Diego seeks 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 oversees CMOs, collaborates with Quality, Regulatory, Clinical, and Supply Chain, and mentors cross-functional teams to mitigate CMC risks and achieve milestones in development and commercialization.