CMC Strategy & Tech Operations Lead - Remote

Travere Therapeutics; Minneapolis (MN); Remote; USD 150,000 - 195,000; Full time

Job summary

Travere Therapeutics is seeking a senior leader to own the CMC strategy for a portfolio of small molecules in development, ensuring timely, cost-effective manufacturing and release of study drug and test articles.

You will collaborate with Quality, Regulatory Affairs, Clinical, Supply Chain, and Program Management to mitigate CMC risks and achieve milestones while engaging external partners for CMO activities.

Qualifications

• Bachelor's degree in Process or Chemical Engineering, Life Sciences, or related discipline.
• 8 years of progressive cGMP related CMC drug development or manufacturing experience.
• Leadership experience in CMC across multiple areas and drug development for small molecules.

Responsibilities

• Provide strategic and technical leadership for technology transfer, scale-up, validation, and cGMP manufacturing across Phase I-III and commercial products.
• Lead the selection, qualification, governance, and performance management of CMOs and external partners to meet scope, quality, timelines, and budget.
• Oversee chemical development of new drug candidates and review regulatory filings, specs, change controls, and Master Batch records.
• Provide technical oversight of CMOs for development, transfer, and maintaining manufacturing/analytical methods; support regulatory inspections and audits.
• Mentor cross-functional teams and author/edit CMC sections of regulatory submissions.

Skills

CMC Leadership

Technology Transfer

CMC Regulatory

Analytical Methods

cGMP Knowledge

Education

Bachelor's degree in Process/Chemical Eng. or Life Sciences

Job description

Travere Therapeutics is seeking a senior leader to own the CMC strategy for a portfolio of small molecules in development, ensuring timely, cost-effective manufacturing and release of study drug and test articles.

You will collaborate with Quality, Regulatory Affairs, Clinical, Supply Chain, and Program Management to mitigate CMC risks and achieve milestones while engaging external partners for CMO activities.