Immunoassay Research Scientist
KCAS is seeking an experienced Immunoassay Research Scientist in our Ligand-binding assay department. He/she will be involved in the development, validation and execution of Biomarker, PK, and Immunogenicity assays in the regulatory compliant environment.
Critical Functions:
- Design, development, validation and execution of Ligand-binding assays including ELISA, RIA, ECL-based assays, cell-based neutralizing antibody assays.
- Writing and review of Standard Operating Procedures, Study Protocols and Bioanalytical Reports.
- Working simultaneous on multiple projects involving method development, validation and study sample analysis.
- Participate in client meetings providing timely updates on project status.
- Collaborate with QA department to assure timely completion of projects and data reporting.
Requirements:
- PhD in biological sciences with at least 2 years of experience in development and validation of ligand-binding assays in a GLP-compliant environment. Outstanding candidates with MS degree in biological sciences and at least 4 years of relevant experience will also be considered.
- Excellent oral and written communication skills. Must be able to write documents that are straightforward with a logical flow of information and are easy to follow and understand the intended message.
- Excellent organizational and analytical skills with ability to effectively handle multiple projects simultaneously.
- Demonstrated ability to work both independently and as part of a multi-disciplinary team in a fast paced multitasking environment.
- Knowledge of FDA bioanalytical method validation guidance is an asset.
- Strong computer skills, including Microsoft Office and statistical analysis software.