Remote Senior Associate Director, Biologics Analytics & Ops
Travere Therapeutics
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Job summary
Travere Therapeutics is seeking an Associate Director, Technical Operations to lead analytical operations for a biologics product. You will develop, validate and transfer analytical methods, and oversee drug substance/product specs at external partners.
The role supports regulatory submissions and collaborates with Quality and Regulatory teams to ensure compliance with US/EU standards. The ideal candidate has 8+ years in analytical development of biologics, experience with HPLC/LC-MS, and strong
Qualifications
- B.S. degree in chemistry, biochemistry, pharmaceutical science, or related Life Sciences required. M.S. preferred.
- 8+ years in analytical development of biologics, preferably in late-stage drug development.
- Knowledge of HPLC, CE-SDS, cIEF, potency bioassays, peptide map, ELISA, LC-MS.
- Experience with external CDMOs/CROs for development, validation and transfer.
Responsibilities
- Manage method development, validation, and transfer for biologics products.
- Oversee specification setting of drug substance/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.
- Support regulatory submissions with analytical data packages.
Skills
Education
Job description
Travere Therapeutics is seeking an Associate Director, Technical Operations to lead analytical operations for a biologics product. You will develop, validate and transfer analytical methods, and oversee drug substance/product specs at external partners.
The role supports regulatory submissions and collaborates with Quality and Regulatory teams to ensure compliance with US/EU standards. The ideal candidate has 8+ years in analytical development of biologics, experience with HPLC/LC-MS, and strong
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