Associate Director, CMC & Tech Transfer

Travere Therapeutics; Denver (CO); Hybrid; USD 150,000 - 195,000; Full time

Benefits offered by this job

Premium health

401(k) match

Paid time off

Job summary

Travere Therapeutics seeks a Senior CMC Leader to drive the development, execution and oversight of the CMC strategy for a portfolio of small molecules. You will coordinate with Quality, Regulatory Affairs, Clinical, Supply Chain and Program Management to manage risks and achieve milestones.

The role requires 8+ years in cGMP CMC, leadership across multiple areas, and experience with small molecules and complex products.

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; small molecules, peptides, biologics.

Responsibilities

• Provide strategic leadership for technology transfer, scale-up, validation, and cGMP manufacturing across Phase I-III clinical development and commercial products.
• Lead the selection, qualification, governance, and performance management of CMOs and external technical service providers, ensuring delivery against scope, quality, timelines, and budget.
• Oversee chemical development of new drug candidates.
• Review regulatory filings, specifications, change controls, and Master Batch records.
• Provide technical oversight of CMOs for regulatory inspections, audits, and cGMP compliance.
• Provide technical leadership and mentorship to colleagues and cross-functional project teams.
• Author/edit CMC sections of regulatory submissions as required.

Skills

CMC leadership

Technology transfer

Regulatory filings

Project management

Team leadership

Education

Bachelors in Process/Chemical Engineering

Job description

Travere Therapeutics seeks a Senior CMC Leader to drive the development, execution and oversight of the CMC strategy for a portfolio of small molecules. You will coordinate with Quality, Regulatory Affairs, Clinical, Supply Chain and Program Management to manage risks and achieve milestones.

The role requires 8+ years in cGMP CMC, leadership across multiple areas, and experience with small molecules and complex products.