Associate Director, Technical Operations – Analytical Development, Biologics

Travere Therapeutics

Associate Director overseeing analytical operations for biologics at Travere Therapeutics. Ensuring compliance with regulatory standards and managing development and transfer processes.

Posted 7/30/2026full-timeSan Diego • California • 🇺🇸 United StatesSenior💰 $150,000 - $195,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in method development, validation, and transfer for biologics products, with a strong focus on compliance with US and EU GMPs and relevant analytical methods. Proven ability to manage reference standard programs and conduct thorough investigations into out-of-specification results.

Highest-signal resume keywords

Analytical Development of BiologicsHPLCMethod ValidationGMP ComplianceRoot Cause Analysis

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Method DevelopmentAnalytical Method ValidationSpecification SettingReference Standard ManagementHPLCCE-SDSCIEFPotency BioassaysELISALC-MS

Industry Keywords

BiologicsCDMOCROOOS InvestigationsOOT InvestigationsCGMPUSPPh. EurICH GuidelinesLyophilized Products

About the role

Key responsibilities & impact

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
Provide scientific and technical support to internal and external groups to ensure that products are manufactured and released in compliance with all applicable regulations

Requirements

What you’ll need

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
Experience with PEGylated and/or lyophilized products is a plus
Maintain up-to-date knowledge of US and EU GMPs, USP, Ph. Eur, and ICH guidelines as applicable to cGMP manufacturing and control of drug substance and drug product
Ability to travel 10-20% domestically and internationally.

Benefits

Comp & perks

premium health
financial
work-life and well-being offerings for eligible employees and dependents
wellness and employee support programs
life insurance
disability
retirement plans with employer match
generous paid time off