Research Scientist - Simply Biotech

TalentZok

Irvine, CA

JOB DETAILS
SALARY
$100,000–$200,000 Per Year
SKILLS
Allergies, Analytical Method Development, Antibodies, Assay Development, Assays, Biochemistry, Biology, Biotech and Pharmaceutical, Calibration, Chemistry, Clinical Information Systems, Clinical Research, Cross-Functional, Data Analysis, Experiment Design, FDA (Food and Drug Administration), Feasibility Analysis, GLP (Good Laboratory Practices), GMP (Good Manufacturing Practices), ISO (International Organization for Standardization), Identify Issues, Immunoassays, Infectious Diseases, Maintain Compliance, Manufacturing Requirements, Medical Diagnosis, Multiplexing, Problem Solving Skills, Process Development, Process Improvement, Quality Control, Quality Metrics, Regulatory Compliance, Reporting Skills, Research & Development (R&D), Scientific Publications, Scientific Research, Statistics, Team Player, Technical Support, Testing, Validation Documentation, Validation Plan
LOCATION
Irvine, CA
POSTED
Today
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
 
Email resumes to

tness@simplybiotech.com

and call 858.258.6501.
       
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
For immediate and confidential consideration, please email your resume to

tness@simplybiotech.com

and call 858.258.6501.
More information can be found at www.simplybiotech.com 


About the Company

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