Associate Director, Analytical Development
Travere Therapeutics
August 06, 2026
Remote friendly (United States)
United States
Operations
Position Summary:
- The Associate Director of Analytical Development, Technical Operations serves as analytical subject matter expert for Travere and is responsible for analytical method development, validation and transfer in compliance with cGMP and international regulatory standards for drug substances and drug products generated by external laboratories and manufacturers.
- Extensive knowledge of FDA, ICH and EU regulatory requirements; ability to work effectively in a virtual environment.
Responsibilities:
- Provide technical leadership and independently manage/oversee method development, validation and transfer at CRO/CMO laboratories for small molecule products.
- Oversee specification setting of drug substance and drug product at CDMOs/CROs.
- Review and approve analytical method validation and method transfer protocols/reports and SOPs.
- Manage development activities (IPC and release testing) and research activities (impurity characterization).
- Provide scientific/technical guidance to internal and external project teams.
- Lead troubleshooting of OOS/OOT root causes and corrective actions.
- Support submission sections for DS/DP analytical package and structural characterization; write technical chemistry reports.
- Support manufacturing and release compliance with applicable regulations.
- Maintain up-to-date knowledge of US/EU GMPs, USP, Ph. Eur, and ICH guidelines.
Education/Experience Requirements:
- B.S. in Chemistry/Biochemistry or related Life Sciences.
- 8+ years analytical development, validation, and transfer experience in biotech/pharma; reviewing analytical data and managing activities from external CRO/CMOs.
- Direct knowledge of HPLC, GC, MS, NMR, IR, dissolution.
Additional Skills/Experience (Preferred):
- Strong communication, collaboration, decision-making, attention to detail; manage multiple priorities.
- Experience with Veeva/Quality Doc a plus.
- Travel 15–20% domestically/internationally; face-to-face/onsite ability in San Diego.
Benefits:
- Premium health, financial, work-life/well-being offerings, life insurance, disability, retirement match, generous paid time off.
- Target base pay range: $150,000.00–$195,000.00.
Application Instructions:
- Travere will accept applications on an ongoing basis until a candidate is selected.
- The Associate Director of Analytical Development, Technical Operations serves as analytical subject matter expert for Travere and is responsible for analytical method development, validation and transfer in compliance with cGMP and international regulatory standards for drug substances and drug products generated by external laboratories and manufacturers.
- Extensive knowledge of FDA, ICH and EU regulatory requirements; ability to work effectively in a virtual environment.
Responsibilities:
- Provide technical leadership and independently manage/oversee method development, validation and transfer at CRO/CMO laboratories for small molecule products.
- Oversee specification setting of drug substance and drug product at CDMOs/CROs.
- Review and approve analytical method validation and method transfer protocols/reports and SOPs.
- Manage development activities (IPC and release testing) and research activities (impurity characterization).
- Provide scientific/technical guidance to internal and external project teams.
- Lead troubleshooting of OOS/OOT root causes and corrective actions.
- Support submission sections for DS/DP analytical package and structural characterization; write technical chemistry reports.
- Support manufacturing and release compliance with applicable regulations.
- Maintain up-to-date knowledge of US/EU GMPs, USP, Ph. Eur, and ICH guidelines.
Education/Experience Requirements:
- B.S. in Chemistry/Biochemistry or related Life Sciences.
- 8+ years analytical development, validation, and transfer experience in biotech/pharma; reviewing analytical data and managing activities from external CRO/CMOs.
- Direct knowledge of HPLC, GC, MS, NMR, IR, dissolution.
Additional Skills/Experience (Preferred):
- Strong communication, collaboration, decision-making, attention to detail; manage multiple priorities.
- Experience with Veeva/Quality Doc a plus.
- Travel 15–20% domestically/internationally; face-to-face/onsite ability in San Diego.
Benefits:
- Premium health, financial, work-life/well-being offerings, life insurance, disability, retirement match, generous paid time off.
- Target base pay range: $150,000.00–$195,000.00.
Application Instructions:
- Travere will accept applications on an ongoing basis until a candidate is selected.