Associate Director, Biologics Analytics & Operations

travere; United States; Hybrid; USD 140,000 - 200,000; Full time

Job summary

Travere Therapeutics in San Diego, USA is seeking an Associate Director, Technical Operations to lead analytical operations for biologics, with expertise in method development, validation and transfer in a cGMP framework.

The role requires a deep knowledge of HPLC, LC-MS, ELISA, and related assays, plus experience collaborating with CDMOs/CROs and preparing regulatory submissions for biologics products aimed at rare diseases.

Qualifications

• B.S. degree in chemistry, biochemistry, pharmaceutical science, or related Life Sciences discipline required. M.S. degree 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

HPLC

CE-SDS

cIEF

Potency bioassays

Peptide mapping

ELISA

LC-MS

Analytical method transfer

Education

B.S. in chemistry or related Life Sciences

M.S. degree preferred

Job description

Travere Therapeutics in San Diego, USA is seeking an Associate Director, Technical Operations to lead analytical operations for biologics, with expertise in method development, validation and transfer in a cGMP framework.

The role requires a deep knowledge of HPLC, LC-MS, ELISA, and related assays, plus experience collaborating with CDMOs/CROs and preparing regulatory submissions for biologics products aimed at rare diseases.