Associate Director, CMC Operations - Remote

Travere Therapeutics; New York (NY); Remote; USD 150,000 - 195,000; Full time

Job summary

Travere Therapeutics is seeking a Senior CMC/CMC Lead to drive the development and manufacturing strategy for a diverse portfolio of small molecules. You will oversee external CMOs, coordinate with Regulatory, Quality, Clinical, and Supply Chain to meet milestones, and ensure compliance with cGMP across development to commercial stages.

You will mentor teams, review regulatory filings, and author CMC sections while ensuring timely delivery of APIs and finished dosage forms.

Qualifications

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

Responsibilities

• Provide strategic and technical leadership for technology transfer, scale-up, validation, and cGMP manufacturing across Phase I-III and commercial products.
• Lead selection, qualification, governance, and performance management of CMOs and external partners.
• Oversee chemical development of new drug candidates.
• Review regulatory filings, specifications, change controls, and Master Batch records.
• Provide technical oversight of CMOs for developing, validating, transferring, and maintaining manufacturing and analytical methods.
• Support regulatory inspections and partner audits.
• Author/edit CMC sections of regulatory submissions.
• Mentor cross-functional teams and drive project milestones.

Skills

CMC leadership

Vendor management

Regulatory collaboration

Process development

cGMP knowledge

Education

Bachelor's degree in Process/ Chemical Engineering or Life Sciences

Job description

Travere Therapeutics is seeking a Senior CMC/CMC Lead to drive the development and manufacturing strategy for a diverse portfolio of small molecules. You will oversee external CMOs, coordinate with Regulatory, Quality, Clinical, and Supply Chain to meet milestones, and ensure compliance with cGMP across development to commercial stages.

You will mentor teams, review regulatory filings, and author CMC sections while ensuring timely delivery of APIs and finished dosage forms.