Associate Director, Biologics Analytics & Ops (Remote)

Travere Therapeutics; Columbus (OH); On-site; USD 150,000 - 195,000; Full time

Job summary

Travere Therapeutics in San Diego, CA, offers a remote-friendly opportunity for an Associate Director, Technical Operations. You will lead analytical method development, validation, and transfer for biologics, ensuring compliance with cGMP and FDA/ICH/EU standards.

We require 8+ years in analytical development of biologics (late-stage preferred), hands-on experience with HPLC, CE-SDS, cIEF, ELISA and LC-MS, and proven collaboration with CDMOs/CROs. Travel 10–20% is expected.

Qualifications

• 8+ years of analytical development experience with biologics, preferably in late-stage drug development.
• Extensive analytical development, validation and transfer with external CDMOs/CROs.
• Strong 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 with root cause analyses and corrective actions.
• Contribute as technical SME in regulatory submissions for analytical packages.

Skills

HPLC

CE-SDS

cIEF

Potency bioassays

Peptide mapping

ELISA

LC-MS

Regulatory knowledge

Education

B.S. in chemistry/biochemistry/pharmaceutical science

M.S. degree preferred

Equivalent combination of education and experience

Job description

Travere Therapeutics in San Diego, CA, offers a remote-friendly opportunity for an Associate Director, Technical Operations. You will lead analytical method development, validation, and transfer for biologics, ensuring compliance with cGMP and FDA/ICH/EU standards.

We require 8+ years in analytical development of biologics (late-stage preferred), hands-on experience with HPLC, CE-SDS, cIEF, ELISA and LC-MS, and proven collaboration with CDMOs/CROs. Travel 10–20% is expected.