Associate Director, Technical Operations (Analytical Development-Biologics)
Travere Therapeutics
August 21, 2026
Remote friendly (San Diego Metropolitan Area)
United States
Operations
Position Summary:
The Associate Director, Technical Operations is responsible for the analytical operations of a biologics product and serves as an analytical subject matter expert. Oversees analytical method development, validation, and transfer in compliance with cGMP and international regulatory standards.
Responsibilities:
- Manage and oversee analytical method development, validation, and transfer for biologics products at CDMOs/CROs.
- Oversee specification setting for drug substance and drug product at CDMOs/CROs.
- Author/review analytical method validation protocols/reports, method transfer protocols/reports, and SOPs.
- Manage reference standard program for drug substance and drug product.
- Review controlled documents (e.g., batch records and CoAs).
- Assist in OOS/OOT investigations; perform root cause analyses and recommend corrective actions.
- Serve as technical subject matter expert for regulatory submissions (analytical package, characterization, reference standard).
- Provide scientific/technical support to internal and external groups to ensure compliant manufacturing and release.
Education/Experience Requirements:
- B.S. in chemistry/biochemistry/pharmaceutical science or related life sciences required; M.S. preferred.
- 8+ years analytical development experience for biologics (preferably late-stage).
- Knowledge of HPLC, CE-SDS, cIEF, potency bioassays, peptide map, ELISA, LC-MS; experience with PEGylated and/or lyophilized products is a plus.
- Experience reviewing analytical data and managing analytical development at external CDMOs/CROs.
Additional Skills/Experience:
- Knowledge of US/EU GMPs, USP, Ph. Eur, and ICH guidelines.
- Ability to adapt to project changes; strong communication, interpersonal, organization, and collaboration skills.
- Ability to manage complex project plans, timelines, budgets, and critical path tasks.
- Travel 10–20%; role not expected to be 100% remote; onsite/face-to-face in San Diego required.
Benefits:
- Premium health and financial/work-life/well-being offerings, life insurance, disability, retirement match, and generous paid time off.
Compensation:
- 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, Technical Operations is responsible for the analytical operations of a biologics product and serves as an analytical subject matter expert. Oversees analytical method development, validation, and transfer in compliance with cGMP and international regulatory standards.
Responsibilities:
- Manage and oversee analytical method development, validation, and transfer for biologics products at CDMOs/CROs.
- Oversee specification setting for drug substance and drug product at CDMOs/CROs.
- Author/review analytical method validation protocols/reports, method transfer protocols/reports, and SOPs.
- Manage reference standard program for drug substance and drug product.
- Review controlled documents (e.g., batch records and CoAs).
- Assist in OOS/OOT investigations; perform root cause analyses and recommend corrective actions.
- Serve as technical subject matter expert for regulatory submissions (analytical package, characterization, reference standard).
- Provide scientific/technical support to internal and external groups to ensure compliant manufacturing and release.
Education/Experience Requirements:
- B.S. in chemistry/biochemistry/pharmaceutical science or related life sciences required; M.S. preferred.
- 8+ years analytical development experience for biologics (preferably late-stage).
- Knowledge of HPLC, CE-SDS, cIEF, potency bioassays, peptide map, ELISA, LC-MS; experience with PEGylated and/or lyophilized products is a plus.
- Experience reviewing analytical data and managing analytical development at external CDMOs/CROs.
Additional Skills/Experience:
- Knowledge of US/EU GMPs, USP, Ph. Eur, and ICH guidelines.
- Ability to adapt to project changes; strong communication, interpersonal, organization, and collaboration skills.
- Ability to manage complex project plans, timelines, budgets, and critical path tasks.
- Travel 10–20%; role not expected to be 100% remote; onsite/face-to-face in San Diego required.
Benefits:
- Premium health and financial/work-life/well-being offerings, life insurance, disability, retirement match, and generous paid time off.
Compensation:
- 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.