Senior Scientist I, Bioanalytics
Vir Biotechnology
- San Francisco, CA
- Permanent
- Full-time
- Develop bioanalytical methods to support large molecule clinical candidates and providing bioanalytical input across all departments and stages of research and development
- Coordinate method development and analysis activities within the context of development plans
- Perform troubleshooting and evaluation of a variety of complex methods to identify appropriate bioanalytical solutions
- Lead technology transfer of bioanalytical methods
- Interact with internal Research, CMC, Operational, and Regulatory groups to support drug development activities
- Responsible for approval of data and reports from external vendors
- PhD with 5+ years /MS and 8+ years/BS and 10+ years of industry experience preferred
- Experience must include a combination of laboratory and project management skills, including managing CROs for assay development and validation for clinical and non-clinical studies
- Demonstrated expertise in GLP and GCP compliance of sample handling and storage, bioanalytical assay development, sample analysis, and laboratory operation and procedures/processes is required
- Technical expertise with a wide variety of platforms to analyze all aspects of large molecule therapeutics, including those with complex sample handling and preparation procedures (e.g., enzymatic assays, ligand-binding assays, cell-based assays, etc.) from a variety of biological matrices (e.g., serum, plasma, etc.)
- Familiar with PK and PD principles pertaining to establishment of relevant assays and assay ranges