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Associate Director, Analytical Development at Travere Therapeutics - ApplyBlast

Associate Director, Analytical Development

Travere Therapeutics

4 months ago

3.7 on Glassdoor

San Diego, CA

Hybrid

Full Time

Senior

0 applicants

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About this role

An Associate Director of Analytical Development leads analytical method development, validation, and transfer for external laboratories, ensuring compliance with cGMP and international regulatory standards. This role involves managing technical reviews, specification setting, and investigation of out-of-specification trends for drug substances and products in the biopharmaceutical industry. The position requires extensive collaboration with Technical Operations, Quality, and Regulatory teams to support clinical development through commercialization.

Responsibilities

Lead analytical method development and transfer at external CROs
Oversee specification setting for drug substances and products
Perform technical reviews and approvals of validation protocols
Investigate OOS/OOT root causes and implement corrective actions
Manage development and research activities for small molecule products

Skills

Qualifications

BS in ChemistryBS in BiochemistryBS in Life Sciences

About Travere Therapeutics

travere.com

Headquarters

San Diego, California, United States

Company Size

201-500 employees

Founded

2020

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Travere Therapeutics is a biopharmaceutical company whose mission is to identify, develop and deliver life-changing therapies to people living with rare disease.