Remote Associate Director, Biologics Analytical Ops

Travere Therapeutics; Detroit (MI); On-site; USD 150,000 - 195,000; Full time

Job summary

Travere Therapeutics is seeking an Associate Director, Technical Operations to lead analytical operations for a biologics product. The role focuses on method development, validation and transfer, ensuring cGMP and regulatory compliance across FDA/ICH/EU standards.

The position requires 8+ years in analytical development of biologics, with strong hands-on experience in HPLC, LC-MS, ELISA and related assays. Travel 10–20% is expected. San Diego-based with on-site requirements.

Qualifications

• 8+ years of analytical development experience for biologics.
• Direct knowledge of HPLC, CE-SDS, cIEF, potency assays, peptide mapping, ELISA and LC-MS.
• Experience with PEGylated or lyophilized products is a plus.
• Experience validating and transferring analytical methods with CDMOs/CROs.

Responsibilities

• Manage method development, validation, and transfer for biologics products at CDMOs/CROs.
• Oversee specification setting for drug substance and drug product at CDMOs/CROs.
• Author/review validation protocols/reports, transfer protocols/reports and SOPs.
• Manage reference standard program for drug substance and drug product.
• Review batch records and CoAs.
• Assist in OOS and OOT investigations; perform root cause analyses and corrective actions.
• Contribute as technical SME in preparation of regulatory submissions for analytical packages.
• Provide scientific support to internal/external groups to ensure compliant manufacturing/release.
• Perform additional duties as needed.

Skills

HPLC

CE-SDS

cIEF

Potency bioassays

Peptide mapping

ELISA

LC-MS

Lyophilized products

Education

BS in chemistry/biochemistry/pharmaceutical science

MS degree preferred

Job description

Travere Therapeutics is seeking an Associate Director, Technical Operations to lead analytical operations for a biologics product. The role focuses on method development, validation and transfer, ensuring cGMP and regulatory compliance across FDA/ICH/EU standards.

The position requires 8+ years in analytical development of biologics, with strong hands-on experience in HPLC, LC-MS, ELISA and related assays. Travel 10–20% is expected. San Diego-based with on-site requirements.