Translational Science Senior Scientist
Job Summary
To support clinical programs, the full-time remote Senior Scientist, Translational Science will manage outsourced bioanalytical activities, focusing on pharmacokinetic, immunogenicity, and biomarker assays while ensuring compliance with regulatory requirements and effective communication with Contract Research Organizations (CROs).
Key Responsibilities
- Manage day-to-day execution of bioanalytical activities for pharmacokinetic, immunogenicity, and biomarker assays at CROs
- Provide scientific input for the design, development, qualification, and validation of bioanalytical methods
- Review assay protocols, validation plans, and bioanalytical data packages for scientific quality and integrity
Required Qualifications
- PhD in biology, biochemistry, pharmacology, chemistry, or related field with 2+ years of relevant experience; or MS with 5+ years of experience in regulated bioanalysis
- Experience with large-molecule pharmacokinetic and immunogenicity assays, including neutralizing antibody methods
- Working knowledge of bioanalytical platforms such as LC-MS/MS, ELISA, and multiplex assays
- Experience engaging and overseeing CROs, including reviewing technical documents and study deliverables
- Knowledge of GLP, GCLP, and bioanalytical regulatory expectations
Complete Job Description
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