Scientist, Immunoassay Development
$129,000–$151,000 year
On-siteSan Carlos, California, United States
Job Summary
Conduct hands-on laboratory work to support immunoassay development, optimization, platform evaluation, method transfer, validation readiness, and routine analytical testing. Execute daily assay operations including execution, reagent preparation, sample handling, study setup, instrument use, data review, documentation, and troubleshooting. Design experiments to support potency, antigenicity, identity, impurity, characterization, comparability, release, and stability needs across ELISA, MSD, bead-based, and multiplex platforms. Generate and interpret data for standard curves, recovery, precision, and system suitability while maintaining accurate ELN entries and study records. Support critical reagent and reference material activities, including qualification, stability studies, and GMP-supporting testing. Collaborate with senior leadership to prioritize laboratory work and coordinate outsourced immunoassay activities.
Required Qualifications
- PHD. in Biochemistry, Immunology, Analytical Chemistry, Biological Sciences, or a related discipline is preferred with 0 to 2 years of relevant biopharmaceutical industry or post-graduate laboratory experience
- M.S. in a related discipline with a minimum of 5 years of relevant biopharmaceutical industry laboratory experience
- B.S. in a related discipline with a minimum of 8 years of relevant biopharmaceutical industry laboratory experience
- Hands-on laboratory experience executing immunoassays in vaccine CMC, biologics analytical development, QC, ASAT, bioanalytical development, or other analytical laboratory environments
- Experience with immunoassay method development or assay execution, including reagent preparation, sample preparation, assay optimization, data analysis, assay controls, and documentation
- Technical experience with ligand-binding immunoassay platforms such as ELISA, MSD, electrochemiluminescence-based assays, bead-based assays, multiplex assays, or other relevant immunoassay technologies
- Experience analyzing immunoassay data, including standard curves, sample response, dilution response, recovery, precision, assay controls, and system suitability criteria
- Experience working in or supporting GMP, GLP, or regulated analytical environments
Desired Qualifications
- Hands-on experience with MSD platforms
- Hands-on experience with multiplex or other multiplex immunoassay platforms
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