Remote: Associate Director, CMC & Tech Operations

Travere Therapeutics; Des Moines (IA); On-site; USD 150,000 - 195,000; Full time

Benefits offered by this job

Premium health insurance

Stock options

Paid time off

Job summary

Travere Therapeutics seeks an experienced CMC leader to develop and oversee the CMC strategy for a diverse portfolio of small molecules. You will manage external manufacturing partners and work with Quality, Regulatory, and Clinical teams to mitigate risks and meet milestones.

The role requires directing technology transfer, scale-up and validation activities, ensuring GMP compliance, and contributing to regulatory submissions. Travel up to 10% is expected.

Qualifications

• Bachelor's degree in Process/Chemical Engineering, Life Sciences, or related discipline (required).
• 8+ years of progressive CMC drug development or manufacturing experience.
• Leadership in CMC across multiple areas and drug development.

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 and Master Batch records.
• Provide technical oversight of CMOs for developing, validating, and maintaining methods for APIs and finished products; support inspections and audits.
• Mentor cross-functional teams; author/edit CMC sections of regulatory submissions.

Skills

Technology transfer

CMC regulatory

Vendor management

Leadership

cGMP

Education

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

Job description

Travere Therapeutics seeks an experienced CMC leader to develop and oversee the CMC strategy for a diverse portfolio of small molecules. You will manage external manufacturing partners and work with Quality, Regulatory, and Clinical teams to mitigate risks and meet milestones.

The role requires directing technology transfer, scale-up and validation activities, ensuring GMP compliance, and contributing to regulatory submissions. Travel up to 10% is expected.