Marin Metro Area, CA
- BioAnalytical Sciences develops analytical methods for detection of drug, antibodies to protein therapeutics, and biomarkers in biological matrices from non-clinical and clinical subjects to support projects through multiple stages of development.
- The Research Associate I will perform bioanalysis, using validated PK or immunoassay methods, on non-clinical and clinical samples in a GLP compliant environment.
- Responsibilities can include sample preparation, sample analysis, GLP documentation, report generation, assay validation and troubleshooting, and interaction with GLP quality assurance unit.
- Required: At least 0-2 years of experience in a bioanalytical laboratory, research laboratory, or biotechnology company performing bioanalytical assays.
- Skills with ELISA and other analytical methods in a GLP-compliant environment, or equivalent analytical experience in a regulated lab environment
- Experience with GLP or GMP documentation and testing.
- Experience with Meso Scale Discovery (MD) and Molecular Devices plate readers
- Experience with Watson LIMS, statistical analysis software, JMP and ELN.
- Excellent writing and verbal communications skills.
- Perform quantitative and semi-quantitative assays on non-clinical and clinical samples such as but not limited to serum, plasma, and urine, including immunoassays (ELISA) for therapeutic protein concentration and antibodies to therapeutic proteins, enzymatic activity assays, and glycosaminoglycans determinations.
- Assist in assay development and qualification of new test methods.
- Prepare SOPs, reports and documents such as assay validation, qualification and maintenance reports.
- Independently perform routine tasks with minimal supervision
- Ensure GLP-compliant sample handling, assay performance and laboratory operations through adherence to SOPs and departmental practices.
- Participate in internal and external inspections/audits.
- Bachelor s degree or equivalent experience with clinical assays or other quantitative analytical methods in a biological or biochemical field.