Associate Director, Biologics Analytics (Remote)

Travere Therapeutics; Columbia (SC); Hybrid; USD 150,000 - 195,000; Full time

Benefits offered by this job

Premium health

Stock options

Paid time off

Job summary

Travere Therapeutics in San Diego, CA is seeking an Associate Director, Technical Operations to lead analytical method development, validation and transfer for a biologics product in a fast-paced, regulated environment.

This role requires 8+ years in analytical development of biologics, hands-on expertise with HPLC, CE-SDS, cIEF, LC-MS, and strong collaboration with CDMOs/CROs, Quality and Regulatory teams.

Qualifications

• B.S. in chemistry, biochemistry, pharmaceutical science or related Life Sciences discipline required. M.S. preferred.
• 8+ years of analytical development experience in biologics, preferably late-stage.
• Direct knowledge of HPLC, CE-SDS, cIEF, ELISA, LC-MS and related methods.

Responsibilities

• Manage 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 batch records and CoAs.
• Assist in OOS and OOT investigations with root cause analyses.
• Contribute to regulatory submissions with analytical packaging info.
• Provide scientific/technical support to ensure compliant manufacturing and release.
• Perform additional duties as needed.

Skills

HPLC

CE-SDS

cIEF

potency bioassays

peptide map

ELISA

LC-MS

Education

B.S. in chemistry/biochemistry/pharmaceutical science

M.S. preferred

Job description

Travere Therapeutics in San Diego, CA is seeking an Associate Director, Technical Operations to lead analytical method development, validation and transfer for a biologics product in a fast-paced, regulated environment.

This role requires 8+ years in analytical development of biologics, hands-on expertise with HPLC, CE-SDS, cIEF, LC-MS, and strong collaboration with CDMOs/CROs, Quality and Regulatory teams.