Biologics Technical Operations — Associate Director (Remote)

Travere Therapeutics; Atlanta (GA); 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, ensuring development, validation, and transfer in compliance with cGMP and global regulatory standards.

Ideal candidate has extensive experience with HPLC, CE-SDS, cIEF, potency assays, and regulatory submissions, along with strong cross-functional collaboration and project management skills.

Qualifications

• BS in chemistry, biochemistry, pharmaceutical science, or related Life Sciences; MS preferred.
• 8+ years of relevant experience in analytical development of biologics, preferably in late-stage drug development.
• Direct knowledge of HPLC, CE-SDS, cIEF, potency bioassays, peptide map, ELISA, LC-MS; PEGylated/lyophilized products a plus.
• Extensive analytical development, validation and transfer background with experience reviewing analytical data and managing activities at external CDMOs/CROs.

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 controlled documents such as batch records and CoAs.
• Assist in OOS and OOT investigations; perform root cause analyses and recommend corrective actions.
• Contribute and act as the technical subject matter expert in preparation of regulatory submissions related to drug substance and drug product analytical package, characterization, reference standard.
• Provide scientific and technical support to internal and external groups to ensure products manufactured and released in compliance with all applicable regulations.
• Additional duties assigned as needed.

Skills

Analytical development

Regulatory knowledge

Cross-functional collaboration

Project management

Education

Bachelor's degree in chemistry/biochemistry/pharma

MS degree preferred

Tools

HPLC

CE-SDS

cIEF

Potency bioassays

Peptide mapping

ELISA

LC-MS

PEGylated products

Lyophilized products

Job description

Travere Therapeutics is seeking an Associate Director, Technical Operations to lead analytical operations for a biologics product, ensuring development, validation, and transfer in compliance with cGMP and global regulatory standards.

Ideal candidate has extensive experience with HPLC, CE-SDS, cIEF, potency assays, and regulatory submissions, along with strong cross-functional collaboration and project management skills.