Marin Metro Area, CA
- 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 development and qualification of new test methods as needed to reach company milestones.
- Prepare or revise SOPs and departmental forms, assay worksheets, deviation investigations and associated GLP documentation.
- Ensure GLP-compliant sample handling, assay performance and laboratory operations through adherence to SOPs and departmental practices
- Interact with BioMarin Corporate Compliance regarding data auditing.
- Participate in internal and external inspections and audits.
- Required: At least 2 years of experience in a bioanalytical laboratory, research laboratory, or biotechnology company performing bioanalytical assays.
- Preferred: Skills with ELISA and other analytical methods in a GLP-compliant environment, or equivalent analytical experience in a regulated lab environment
- Preferred: Experience with GLP or GMP documentation and testing.
- Preferred: Excellent writing and verbal communications skills.
- Bachelor's degree or equivalent experience with clinical assays or other quantitative analytical methods in a biological or biochemical field.