Biologics Analytical Operations Lead (Remote)

Travere Therapeutics; Des Moines (IA); On-site; USD 150,000 - 195,000; Full time

Benefits offered by this job

Health insurance

Stock options

Paid time off

Job summary

Travre Therapeutics is seeking an Associate Director, Technical Operations to lead the analytical operations for a biologics drug product. You will develop, validate, and transfer analytical methods and oversee transfer at CDMOs/CROs to ensure regulatory compliance.

You will support regulatory submissions, manage reference standards, and collaborate with Quality, Regulatory, and Manufacturing to advance programs for rare disease therapies.

Qualifications

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

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 and SOPs.
• Manage reference standard program for drug substance/product.
• Review batch records and COAs.
• Assist in OOS/OOT investigations and root cause analysis.
• Contribute to regulatory submissions for analytical packages.
• Provide scientific support to ensure regulatory compliance.

Skills

Analytical development

HPLC

CE-SDS

cIEF

LC-MS

Regulatory knowledge

Education

B.S. in Chemistry/Biochemistry/Pharmaceutical Science

MS degree preferred

Job description

Travre Therapeutics is seeking an Associate Director, Technical Operations to lead the analytical operations for a biologics drug product. You will develop, validate, and transfer analytical methods and oversee transfer at CDMOs/CROs to ensure regulatory compliance.

You will support regulatory submissions, manage reference standards, and collaborate with Quality, Regulatory, and Manufacturing to advance programs for rare disease therapies.