Sr. Specialist, Bioanalytics
$89,900–$143,800 year
On-siteCambridge, Massachusetts, United States or Research, Victoria, Australia
Job Summary
Analyze data from external vendors for ligand binding assays and ELISA to quantify protein analytes in nonclinical species, supporting Investigational New Drug filings. Manage method transfer, validation, and troubleshooting for bioanalytical methods including PK, LBA, bDNA, and qPCR. Develop quantitative assays and review study designs, workflows, and Standard of Work documents to enable study conduct. Collaborate cross-functionally on best practices for laboratory techniques and CRO qualifications while maintaining proficiency with current scientific regulations. Provide summary presentations and detailed reports to internal and external stakeholders.
Required Qualifications
- Master's degree in Biotechnology, Microbiology, or related field
- Bachelor's degree in Biotechnology, Microbiology, or related field
- Three (3) years of experience in the offered position or as a Research Associate or related position
- Five (5) years of progressive post-baccalaureate experience in the stated positions
- Bioanalytical Assays, including Ligand Binding Assays and hybridization-based quantitative bioanalytical methods to measure analytes in biological samples
- Bioanalytical Method Qualification, Method transfer, and Method Validation
- Bioanalytical method development for evaluating PK/Toxicokinetic, safety, and efficacy endpoints for non-clinical and platform programs
- Performing sample analysis, troubleshooting and bioanalytical reports for assay validation
- Quantifying protein analytes in non-clinical species and matrices
- Troubleshooting and refining assay conditions to improve accuracy and reliability using knowledge of immunology and pharmacology
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