Biologics Analytical Operations Leader

Travere Therapeutics

Oklahoma City (OK)

Hybrid

USD 150,000 - 195,000

Full time

14 days+

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Benefits offered by this job

Premium health

Financial planning

Work-life and wellbeing offerings

Life insurance

Retirement plans with employer match

Generous paid time off

Job summary

Travere Therapeutics is seeking an Associate Director, Technical Operations in San Diego to lead analytical method development, validation and tech transfer for biologics under cGMP and global regulatory standards.

The role requires 8+ years in analytical biology, expertise in HPLC/CE-SDS/cIEF/LC-MS/ELISA, and collaboration across Technical Operations, Quality and Regulatory. Hybrid work with travel 10-20% is expected.

Qualifications

8+ years of relevant experience in analytical development of biologics.
Direct knowledge of HPLC, CE-SDS, cIEF, potency bioassays, peptide map, ELISA, LC-MS.
Experience with PEGylated and/or lyophilized products is a plus.
Extensive analytical development, validation and transfer with external CDMOs/CROs.

Responsibilities

Manage method development, validation, and transfer for biologics at CDMOs/CROs.
Oversee specification setting of drug substance and 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 and perform root cause analyses.