Associate Director, Technical Operations (Analytical Development-Biologics)
Travere Therapeutics
August 21, 2026
Remote friendly (United States)
United States
Operations
Position Summary:
Associate Director, Technical Operations responsible for analytical operations for a biologics product and serves as analytical subject matter expert. Leads analytical method development, validation, and transfer per cGMP and international regulatory standards; collaborates with Technical Operations, Quality, and Regulatory.
Responsibilities:
- Manage/oversee analytical method development, validation, and transfer for biologics at CDMOs/CROs.
- Oversee drug substance/drug product specification setting at CDMOs/CROs.
- Author/review analytical method validation and method transfer protocols/reports and SOPs.
- Manage reference standard program for drug substance and drug product.
- Review controlled documents (batch records, CoAs).
- Support OOS/OOT investigations; perform root cause analysis and corrective actions.
- Act as technical SME for regulatory submissions (analytical package, characterization, reference standards).
- Provide scientific/technical support to ensure compliant manufacturing and release.
Qualifications/Experience:
- B.S. in chemistry/biochemistry/pharmaceutical science or related life sciences required (M.S. preferred).
- 8+ years analytical development experience in biologics (preferably late-stage).
- Knowledge of HPLC, CE-SDS, cIEF, potency bioassays, peptide map, ELISA, LC-MS; plus PEGylated and/or lyophilized products.
- Extensive analytical development/validation/transfer experience; experience reviewing data and managing external CDMOs/CROs.
Additional Skills:
- Knowledge of US/EU GMPs, USP, Ph. Eur, ICH.
- Strong communication, organization, collaboration; manage complex project plans/timelines/budgets.
- Travel 10–20%.
Benefits:
- Premium health, life insurance, disability, retirement with match, and generous paid time off; wellness/employee support programs.
- Target base pay range: $150,000–$195,000.
Application Instructions:
- Applications accepted on an ongoing basis until a candidate is selected.
Associate Director, Technical Operations responsible for analytical operations for a biologics product and serves as analytical subject matter expert. Leads analytical method development, validation, and transfer per cGMP and international regulatory standards; collaborates with Technical Operations, Quality, and Regulatory.
Responsibilities:
- Manage/oversee analytical method development, validation, and transfer for biologics at CDMOs/CROs.
- Oversee drug substance/drug product specification setting at CDMOs/CROs.
- Author/review analytical method validation and method transfer protocols/reports and SOPs.
- Manage reference standard program for drug substance and drug product.
- Review controlled documents (batch records, CoAs).
- Support OOS/OOT investigations; perform root cause analysis and corrective actions.
- Act as technical SME for regulatory submissions (analytical package, characterization, reference standards).
- Provide scientific/technical support to ensure compliant manufacturing and release.
Qualifications/Experience:
- B.S. in chemistry/biochemistry/pharmaceutical science or related life sciences required (M.S. preferred).
- 8+ years analytical development experience in biologics (preferably late-stage).
- Knowledge of HPLC, CE-SDS, cIEF, potency bioassays, peptide map, ELISA, LC-MS; plus PEGylated and/or lyophilized products.
- Extensive analytical development/validation/transfer experience; experience reviewing data and managing external CDMOs/CROs.
Additional Skills:
- Knowledge of US/EU GMPs, USP, Ph. Eur, ICH.
- Strong communication, organization, collaboration; manage complex project plans/timelines/budgets.
- Travel 10–20%.
Benefits:
- Premium health, life insurance, disability, retirement with match, and generous paid time off; wellness/employee support programs.
- Target base pay range: $150,000–$195,000.
Application Instructions:
- Applications accepted on an ongoing basis until a candidate is selected.