This position is responsible for the development and validation of clinical serological assays in support of novel vaccine candidates. The position is responsible for testing of clinical samples and the maintenance of relevant equipment following GCLP guidance. The position is also responsible for the monitoring of clinical serological assay performed at contract testing facilities.
The candidate will be responsible for the development and optimization of serological assays to support vaccine candidates in clinical trials. The candidate should be familiar with assay development and optimization (e.g. performing DOEs) of serological assays for both ligand binding (multiplex, e.g. Luminex) and functional assay (i.e. cell based microneutralization assays) platforms. The role may also include some collaboration on the development of relevant CMI assays. The candidate will be expected to design and perform experiments independently, perform data analysis and suggest assay optimizations based on data collected and collaboration with team. The candidate will also need to successfully qualify and validate assays for GCLP testing.
Assist with the transfer of novel clinical assays to contract testing facilities and monitoring according to GCLP. Assist with monitoring assay validation and assay performance at contract testing facilities. Includes reviewing protocols, reports and some basic data analysis. Interacts with external parties.
Documentation and presentation of scientific results. Maintains lab notebooks. Writing of SOPs, protocols and reports (both internal and external) and comfortable preparing summary power point presentations for cross-functional teams.
Interact with the research group for the development of novel assays and with their deployment/transfer to a regulated clinical testing environment.
- MS or PhD in chemistry, biochemistry, molecular biology or immunology
- MS with 10+ year or PhD with 0-3 year’s academic or pharmaceutical/biotech experience in vaccine development
- Broad functional expertise and demonstrable scientific knowledge of ligand binding assay (including multiplexing)
- Ability to develop and implement new assays with minimal guidance
- Understands and recognizes the impact and implications of data
- Working knowledge of GCLPs
- Experience with basic data analysis (e.g. GraphPad) and presentation software
- Strong organizational, written and oral communication skills
- Ability to work within a matrixed team environment is essential.
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