Research Scientist - 22168

Job Description

Job Description

Research Scientist - Simply Biotech

OVERVIEW

Are you looking for a new career opportunity with an exciting biotech company?! Then we have got the right team for you! In this role, you are responsible for the duties listed below.

Immediate opening for a Research Scientist in Irvine, CA who possess:

• Experience developing immunoassays for Phadia or IMMULITE systems
• Bachelors, Masters, or Ph. D in biochemistry, life science, biology, chemistry or a related field
• Experience with establishing QC systems, process development, or process improvement

FULL DESCRIPTION : We are seeking a highly motivated Research Scientist with expertise in immunoassay development and optimization, particularly on automated diagnostic platforms such as Phadia System and/or IMMULITE. The ideal candidate will have hands-on experience creating QC systems for, developing, validating, and troubleshooting immunoassays for clinical or research applications, with a strong understanding of assay performance characteristics, reagent development, and analytical methods.

The selected candidate will be responsible for:

• Design, develop, optimize, and validate immunoassays for automated platforms including Phadia and/or IMMULITE systems.
• Perform assay feasibility studies, analytical validation, and troubleshooting activities.
• Develop and optimize assay components including antibodies, antigens, calibrators, controls, and buffers.
• Analyze experimental data and prepare technical reports, protocols, and validation documentation.
• Collaborate cross-functionally with R&D, Quality, Regulatory, Manufacturing, and Clinical teams.
• Support technology transfer and scale-up activities for assay commercialization.
• Ensure compliance with applicable regulatory and quality standards (e.g., GLP, GMP, CLIA, ISO 13485, FDA guidance).
• Stay current with advances in immunodiagnostics, biomarkers, and assay technologies.

The selected candidate will also possess:

• Direct hands-on experience with Phadia and/or IMMULITE assay platforms.
• Strong knowledge of immunoassay techniques including ELISA, chemiluminescence, fluorescence, or multiplex assays.
• Experience with assay validation parameters including sensitivity, specificity, precision, linearity, and reproducibility.
• Proficiency in experimental design, statistical analysis, and scientific documentation.
• Excellent problem-solving, communication, and collaboration skills.
• Experience in allergy, autoimmune, or infectious disease diagnostics.

Salary Range: $100-200k/year

More information can be found at

Simply Biotech was founded in 2008 and has been repeatedly recognized as one of San Diego County's fastest growing businesses. In 2025, we were named Business Journal's 'Best Places to Work'. Even as our competitors are scaling back and laying off staff, Simply Biotech is expanding to new markets and hiring additional staff in existing offices.

Company Description

Simply Biotech was founded in 2008 and has been repeatedly recognized as one of San Diego County's fastest growing businesses. In 2025, we were named Business Journal's 'Best Places to Work'. Even as our competitors are scaling back and laying off staff, Simply Biotech is expanding to new markets and hiring additional staff in existing offices.