Remote Associate Director, CMC Operations

Travere Therapeutics

Providence (RI)

On-site

USD 150,000 - 195,000

Full time

4 days ago

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Job summary

Travere Therapeutics is seeking a highly experienced CMC leader to drive the development, transfer, and scale-up of small molecule programs. The role oversees CMOs, maintains regulatory readiness, and collaborates with Quality, Regulatory, Clinical, Supply Chain, and Program Management to mitigate risks and meet milestones.

The ideal candidate has 8+ years in cGMP CMC, strong leadership, and deep knowledge of APIs, finished dosage forms, and diverse modalities.

Qualifications

Bachelor's degree required in a relevant science or engineering field.
8+ years of progressive cGMP related CMC drug development or manufacturing experience.
Demonstrated leadership in CMC across multiple related areas and drug development.

Responsibilities

Strategic leadership for technology transfer, scale-up, validation and cGMP manufacturing across Phase I-III and commercial products.
Lead the selection, qualification, governance and performance management of CMOs and external partners, ensuring scope, quality 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 APIs and finished dosage forms; support inspections and audits.
Mentor cross-functional teams and author/edit CMC sections of regulatory submissions.
Additional duties as needed.