Associate Director, Technical Ops – Biologics Analytics (Hybrid/Remote)

Travere Therapeutics; San Diego, Northern (CA, KY); Hybrid; USD 150,000 - 195,000; Full time

Benefits offered by this job

Premium health benefits

Well-being offerings

Life insurance

Disability

Retirement plans with employer match

Generous paid time off

Job summary

Travere Therapeutics in San Diego, USA (Remote) is seeking an Associate Director, Technical Operations to lead analytical development for a biologics program. You will oversee method development, validation and transfer, ensuring cGMP compliance and alignment with regulatory expectations.

The role requires 8+ years in analytical development of biologics, strong experience with HPLC, CE-SDS, cIEF, LC-MS and related assays, and collaboration across CDMOs/CROs, Quality, and Regulatory teams.

Qualifications

• 8+ years in analytical development of biologics, preferably in late-stage drug development.
• Direct knowledge of FDA, ICH and EU regulatory requirements for cGMP manufacturing and control.

Responsibilities

• 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.
• Contribute as technical SME in regulatory submissions for analytical packages.
• Provide scientific support to ensure compliance with regulations.

Skills

HPLC

CE-SDS

cIEF

Potency bioassays

Peptide mapping

ELISA

LC-MS

Lyophilized products experience

Education

B.S. in Chemistry/Biochemistry/Pharmaceutical Science

M.S. degree preferred

Job description

Travere Therapeutics in San Diego, USA (Remote) is seeking an Associate Director, Technical Operations to lead analytical development for a biologics program. You will oversee method development, validation and transfer, ensuring cGMP compliance and alignment with regulatory expectations.

The role requires 8+ years in analytical development of biologics, strong experience with HPLC, CE-SDS, cIEF, LC-MS and related assays, and collaboration across CDMOs/CROs, Quality, and Regulatory teams.