Associate Director, Analytical Operations - Biologics
Travere Therapeutics
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Benefits offered by this job
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, ensuring cGMP compliance and alignment with FDA/ICH/EU standards.
The role collaborates with Quality, Regulatory and Tech Ops teams to enable development through commercialization of therapies for rare diseases. The position requires strong scientific leadership, experience with external CDMOs/CROs, and the
Qualifications
- BS degree in chemistry, biochemistry, pharmaceutical science, or related Life Sciences; MS preferred.
- 8+ years of analytical development experience for biologics.
- Knowledge of HPLC, CE-SDS, cIEF, potency bioassays, peptide mapping, ELISA, LC-MS.
- Experience with PEGylated and/or lyophilized products is a plus.
- Extensive development, validation, and transfer with CDMOs/CROs.
Responsibilities
- Manage method development, validation, and transfer for biologics.
- Oversee drug substance/product specifications at CDMOs/CROs.
- Author/review validation/transfer protocols 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 data.
- Provide technical support to internal/external teams for compliance.
- Additional duties as needed.
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, ensuring cGMP compliance and alignment with FDA/ICH/EU standards.
The role collaborates with Quality, Regulatory and Tech Ops teams to enable development through commercialization of therapies for rare diseases. The position requires strong scientific leadership, experience with external CDMOs/CROs, and the
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