Associate Director, CMC Operations

Travere Therapeutics; Salt Lake City (UT); Remote; USD 150,000 - 195,000; Full time

Benefits offered by this job

Premium health benefits

Work-life and well-being offerings

Life insurance

Retirement plans with employer match

Generous paid time off

Job summary

Travere Therapeutics, a biopharmaceutical company focused on rare diseases, is seeking a Senior Director of Technical Operations to lead CMC strategy for a portfolio of small molecules in development, ensuring timely and compliant manufacturing of test articles and products.

You will oversee external manufacturing partners, collaborate with Quality, Regulatory Affairs, Clinical, Supply Chain, and Program Management to mitigate CMC risks and achieve milestones, including overseeing regulatory

Qualifications

• Bachelor's degree in Process or Chemical Engineering, Life Sciences, or related discipline required. Equivalent combination of education and applicable job experience may be considered.
• 8 years of progressive cGMP related CMC drug development or manufacturing experience required.
• Leadership experience in CMC across multiple areas and drug development with small molecules, peptides, and biologics of varying degrees of complexity.

Responsibilities

• Provide strategic and technical leadership for technology transfer, scale-up, validation, and cGMP manufacturing activities across Phase I-III clinical development and commercial products.
• Lead the selection, qualification, governance, and performance management of CMOs, collaboration partners, and other external technical service providers, ensuring delivery against agreed 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 responsible for developing, validating, transferring, and maintaining manufacturing and analytical methods for clinical and commercial production of APIs and finished dosage forms. Support regulatory inspections, partner audits, and ongoing compliance with applicable cGMP requirements and global regulatory expectations.
• Provide technical leadership and mentorship to colleagues and cross-functional project teams.
• Author/edit CMC sections of regulatory submissions as required
• Additional duties assigned as needed.

Skills

Technology transfer

CMO management

cGMP compliance

Leadership

Cross-functional collaboration

Education

Bachelor's degree in Process or Chemical Engineering

Job description

Travere Therapeutics, a biopharmaceutical company focused on rare diseases, is seeking a Senior Director of Technical Operations to lead CMC strategy for a portfolio of small molecules in development, ensuring timely and compliant manufacturing of test articles and products.

You will oversee external manufacturing partners, collaborate with Quality, Regulatory Affairs, Clinical, Supply Chain, and Program Management to mitigate CMC risks and achieve milestones, including overseeing regulatory