Remote Associate Director Biologics Analytical Ops

Travere Therapeutics; Minneapolis (MN); Hybrid; USD 150,000 - 195,000; Full time

Benefits offered by this job

Premium health coverage

Stock options

Generous paid time off

Job summary

Travere Therapeutics in San Diego, USA, seeks an Associate Director, Technical Operations to lead analytical method development, validation, and transfer for a biologics program, ensuring cGMP compliance and international regulatory readiness.

This role collaborates with Technical Operations, Quality, and Regulatory teams, overseeing CDMO/CRO interactions, reference standards, and support for regulatory submissions, with travel requiring up to 20% domestically and internationally.

Qualifications

• Requires B.S. degree in chemistry, biochemistry, pharmaceutical science, or related Life Sciences; M.S. preferred.
• 8+ years in analytical development of biologics, preferably late-stage.
• Extensive experience with HPLC, CE-SDS, cIEF, potency assays, ELISA, LC-MS and related methods.

Responsibilities

• Manage method development, validation, and transfer for biologics.
• Oversee specification setting for drug substance and drug product at CDMOs/CROs.
• Author/review validation protocols/reports and SOPs.
• Manage reference standard program for drug substance and product.
• Review batch records and CoAs.
• Assist in OOS and OOT investigations and root cause analyses.
• Support regulatory submissions for analytic package and characterization.
• Provide scientific support to ensure compliant manufacturing and release.

Skills

HPLC

CE-SDS

cIEF

potency bioassays

peptide map

ELISA

LC-MS

PEGylated products

Education

B.S. degree in chemistry/biochemistry/pharmaceutical science

M.S. degree preferred

Job description

Travere Therapeutics in San Diego, USA, seeks an Associate Director, Technical Operations to lead analytical method development, validation, and transfer for a biologics program, ensuring cGMP compliance and international regulatory readiness.

This role collaborates with Technical Operations, Quality, and Regulatory teams, overseeing CDMO/CRO interactions, reference standards, and support for regulatory submissions, with travel requiring up to 20% domestically and internationally.