Associate Director, Biologics Analytics & Ops (Remote)
Travere Therapeutics
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Benefits offered by this job
Job summary
Travere Therapeutics, located in San Diego with remote work options, is seeking an Associate Director of Technical Operations to lead analytical operations for biologics. The role requires expert method development, validation, and transfer oversight across CDMOs/CROs, ensuring adherence to cGMP and global regulatory standards.
The candidate will collaborate with Technical Operations, Quality, and Regulatory, supporting clinical development through commercialization.
Qualifications
- B.S. degree in chemistry, biochemistry, pharmaceutical science, or related Life Sciences required; M.S. preferred.
- 8+ years in analytical development of biologics, ideally late-stage.
- Extensive experience with analytical methods and regulatory knowledge (FDA, ICH, EU).
- Experience with external CDMOs/CROs for development activities.
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 validation and transfer 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 analyses.
- Support regulatory submissions with analytical package information.
Skills
Education
Job description
Travere Therapeutics, located in San Diego with remote work options, is seeking an Associate Director of Technical Operations to lead analytical operations for biologics. The role requires expert method development, validation, and transfer oversight across CDMOs/CROs, ensuring adherence to cGMP and global regulatory standards.
The candidate will collaborate with Technical Operations, Quality, and Regulatory, supporting clinical development through commercialization.
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