Associate Director, Analytical Development
Travere Therapeutics
June 25, 2026
Remote friendly (United States)
United States
Operations
Position Summary:
- Associate Director of Analytical Development, Technical Operations serves as analytical subject matter expert responsible for analytical method development, validation and transfer (cGMP and international regulatory standards) for drug substances and drug products from external labs/manufacturers. Extensive knowledge of FDA, ICH and EU 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 protocol/reports, method transfer protocol/reports, SOPs, and experimental reports.
- Manage development activities (IPC, release testing) and research activities (impurity characterization).
- Provide scientific/technical guidance to internal and external teams.
- Troubleshoot OOS/OOT root causes; evaluate and drive corrective actions.
- Support submission sections for DS/DP analytical package and structural characterization.
- Write technical chemistry reports; support compliant manufacturing and release.
- 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 (or equivalent).
- 8+ years analytical development/validation/transfer experience in biotech/pharma, including reviewing analytical data and managing activities via external CRO/CMOs.
- Direct knowledge of HPLC, GC, MS, NMR, IR, dissolution, and other analytical methods.
Additional Skills/Experience:
- Courage, community spirit, patient focus, teamwork; strong communication; attention to detail; manage multiple priorities.
- Teamwork; decision-making/collaboration.
- Veeva/Quality Doc experience (plus).
- Travel 15–20% domestically/internationally; not 100% remote.
Benefits:
- Premium health, financial, work-life/well-being offerings; wellness/support programs; life insurance, disability; retirement match; generous paid time off.
Compensation:
- Target base pay range: $150,000–$195,000.
Application:
- Travere will accept applications on an ongoing basis until a candidate is selected.
- Associate Director of Analytical Development, Technical Operations serves as analytical subject matter expert responsible for analytical method development, validation and transfer (cGMP and international regulatory standards) for drug substances and drug products from external labs/manufacturers. Extensive knowledge of FDA, ICH and EU 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 protocol/reports, method transfer protocol/reports, SOPs, and experimental reports.
- Manage development activities (IPC, release testing) and research activities (impurity characterization).
- Provide scientific/technical guidance to internal and external teams.
- Troubleshoot OOS/OOT root causes; evaluate and drive corrective actions.
- Support submission sections for DS/DP analytical package and structural characterization.
- Write technical chemistry reports; support compliant manufacturing and release.
- 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 (or equivalent).
- 8+ years analytical development/validation/transfer experience in biotech/pharma, including reviewing analytical data and managing activities via external CRO/CMOs.
- Direct knowledge of HPLC, GC, MS, NMR, IR, dissolution, and other analytical methods.
Additional Skills/Experience:
- Courage, community spirit, patient focus, teamwork; strong communication; attention to detail; manage multiple priorities.
- Teamwork; decision-making/collaboration.
- Veeva/Quality Doc experience (plus).
- Travel 15–20% domestically/internationally; not 100% remote.
Benefits:
- Premium health, financial, work-life/well-being offerings; wellness/support programs; life insurance, disability; retirement match; generous paid time off.
Compensation:
- Target base pay range: $150,000–$195,000.
Application:
- Travere will accept applications on an ongoing basis until a candidate is selected.