BioPhase Solutions specializes in recruiting top talented professionals for San Diego's Scientific community. We are currently looking for a Project Analyst to work for a leading San Diego biotechnology company.
Company is laboratory experienced in preclinical and clinical studies which involve development, validation and optimization of custom assays and existing methods.
Perform quantitative, qualitative, semi-qualitative and biomarker assays by ELISA according to GLP guidelines
Develop and validate analytical assays to meet in-house and client protocols.
Perform linearity, drug interference, selectivity and qualification of new reagents according to individual assays.
Organize and QC raw data notebooks and final validation reports.
Maintain accurate records regarding client samples, data, reports and reagents.
Create and maintain SOP's, Bioanalytical Procedures and personal training file.
Prepare buffers including: coat, block, wash and assay buffer specific to each assay.
Perform calibration and routine maintenance of laboratory equipment including: pipettes, pH meter, centrifuge, plate washers and readers.
Handle, store and discard specimens and reagents according to bio-hazard protocols.
Extensive experience working with FDA-GLP standards.
Implementation and validation of custom ligand binding assays.
Optimization and validation of existing (kit) ELISA methods for proprietary compounds.
ELISA analysis of clinical and pre-clinical samples (40-60 assays/month).
Detection of Anti-Drug antibodies in the presence of drug.
Meso Scale technology used to characterize ultra-sensitive binding events
Quantitative and qualitative assay experience
Biomarker assays with a variety of matrices
BioPhase Solutions - 10 months ago