Remote: Associate Director, Biologics Analytical Operations

Travere Therapeutics; Manchester (NH); On-site; USD 150,000 - 195,000; Full time

Job summary

Travere Therapeutics in San Diego seeks an Associate Director, Technical Operations to lead analytical operations for a biologics product, developing, validating and transferring analytical methods in compliance with cGMP and global standards. The role requires collaboration with Quality, Regulatory and Clinical teams to support development through commercialization of a rare-disease therapy.

You will oversee method development, validation and transfer at CDMOs/CROs, manage reference standards,

Qualifications

• 8+ years in analytical development of biologics.
• Experience with HPLC, CE-SDS, cIEF, LC-MS, ELISA.
• Experience with CDMOs/CROs and regulatory submissions.

Responsibilities

• Oversee method development, validation, and transfer for biologics.
• Set specifications for drug substance and product at CDMOs/CROs.
• Author/review validation protocols, transfer protocols, and SOPs.
• Manage reference standard program for drug substance and product.
• Review batch records and CoAs.
• Assist in OOS and OOT investigations; root cause analyses.
• Support regulatory submissions with analytical package.
• Provide scientific/technical support to ensure regulatory compliance.
• Perform other duties as needed.

Skills

HPLC

CE-SDS

cIEF

Potency assays

Peptide mapping

ELISA

LC-MS

CDMO experience

Education

Bachelor's degree in Life Sciences

MS degree preferred

Job description

Travere Therapeutics in San Diego seeks an Associate Director, Technical Operations to lead analytical operations for a biologics product, developing, validating and transferring analytical methods in compliance with cGMP and global standards. The role requires collaboration with Quality, Regulatory and Clinical teams to support development through commercialization of a rare-disease therapy.

You will oversee method development, validation and transfer at CDMOs/CROs, manage reference standards,