Remote Associate Director, CMC & Tech Operations

Travere Therapeutics; Columbus (OH); Hybrid; USD 150,000 - 195,000; Full time

Job summary

Travere Therapeutics in San Diego (hybrid) seeks a Senior Director, Technical Operations to lead the CMC strategy for a diverse portfolio of small molecules in development and manufacturing. You will oversee external CMOs, coordinate with Quality, Regulatory Affairs, Clinical, and Supply Chain, and drive risk mitigation to achieve milestones.

The role requires 8+ years in cGMP CMC drug development or manufacturing, strong leadership, and experience with small molecules, peptides, or biologics.

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.
• Must show demonstrated leadership experience in CMC: preferably in more than one related CMC area, and drug development experience with small molecules (both oral and injectable), 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

Leadership

Communication

Teamwork

CMC knowledge

cGMP

CMO management

Project management

Education

Bachelor's degree in Process or Chemical Engineering, Life Sciences, or related discipline

Job description

Travere Therapeutics in San Diego (hybrid) seeks a Senior Director, Technical Operations to lead the CMC strategy for a diverse portfolio of small molecules in development and manufacturing. You will oversee external CMOs, coordinate with Quality, Regulatory Affairs, Clinical, and Supply Chain, and drive risk mitigation to achieve milestones.

The role requires 8+ years in cGMP CMC drug development or manufacturing, strong leadership, and experience with small molecules, peptides, or biologics.