Biologics Analytical Operations Lead

Travere Therapeutics; Boston (MA); On-site; USD 150,000 - 195,000; Full time

Benefits offered by this job

Health insurance

Retirement plans

Job summary

Travere Therapeutics is seeking an Associate Director of Technical Operations in San Diego. You will lead analytical method development, validation, and transfer for biologics, ensuring cGMP compliance and alignment with FDA/ICH/EU regulations.

This role collaborates across Technical Operations, Quality, and Regulatory to support clinical development through commercialization. The position requires extensive experience with HPLC, CE-SDS, cIEF, and related assays, and a track record of managing

Qualifications

• B.S. degree in chemistry, biochemistry, pharmaceutical science, or related Life Sciences discipline required. M.S. preferred.
• 8+ years of relevant experience in analytical development of biologics, preferably in late-stage drug development.
• Direct knowledge of HPLC, CE-SDS, cIEF, potency bioassays, peptide map, ELISA, LC-MS and other relevant analytical methods.
• Extensive analytical development, validation and transfer background with experience reviewing analytical data and managing analytical development activities at external CDMOs/CROs.

Responsibilities

• Manage and oversee method development, validation, and transfer for biologics products at CDMOs/CROs.
• Oversee specification setting of drug substance and drug product at CDMOs/CROs.
• Author/review analytical method validation protocol/report, method transfer protocol/report and SOPs.
• Manage reference standard program for drug substance and drug product.
• Review controlled documents such as batch records and CoAs.
• Assist in OOS and OOT investigations. Perform root cause analyses and recommend corrective actions.
• Contribute and act as the technical subject matter expert in preparation of regulatory submissions related to drug substance and drug product analytical package, characterization, reference standard.
• Provide scientific and technical support to internal and external groups to ensure that products are manufactured and released in compliance with all applicable regulations.
• Additional duties assigned as needed.

Skills

Analytical development

Regulatory knowledge

cGMP

HPLC

ELISA

LC-MS

Collaboration

Education

B.S. in chemistry/biochemistry/pharmaceutical science

M.S. preferred

Tools

HPLC

CE-SDS

cIEF

Potency bioassays

Peptide map

Reference standards management

Job description

Travere Therapeutics is seeking an Associate Director of Technical Operations in San Diego. You will lead analytical method development, validation, and transfer for biologics, ensuring cGMP compliance and alignment with FDA/ICH/EU regulations.

This role collaborates across Technical Operations, Quality, and Regulatory to support clinical development through commercialization. The position requires extensive experience with HPLC, CE-SDS, cIEF, and related assays, and a track record of managing