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Senior Scientist – Immunoassay and PCR Development

2 months ago

Marquand, Missouri, United States Early is Good Full time
About the Role

We are seeking a highly skilled Senior Scientist to join our Assay Product Development team at Early is Good. As a key member of our team, you will be responsible for driving the advancement of our proprietary nanotechnology multi-omics assay portfolio.

Key Responsibilities
  • Develop and execute experiments to support late-phase development activities for DNA/RNA and protein Immunoassays on various types of biological specimens.
  • Provide technical expertise for immunoassay and PCR development activities, including assay development, optimization, calibrator and control evaluations, design verification and validation.
  • Plan development activities, execute experiments and studies, and document results within a design change control environment in accordance with appropriate regulatory guidelines.
  • Apply analytical and statistical techniques to diagnose performance issues, develop and test solutions, and implement improvements to reduce variability and enhance the quality of test results.
  • Develop conclusions and effectively communicate results to both internal and external audiences.
Requirements
  • At least 5 years of industry experience in immunoassay development.
  • Strong desire to develop and commercialize best-in-class ultrasensitive immunoassays for oncology diseases.
  • Self-starter, adaptable, and action-driven, capable of thriving in a fast-paced environment.
  • Experience with assay development in blood/urine-based immunoassays.
  • Experience working in a regulated environment that may include GLP or CLIA.
  • Experience in developing validation plans for immunoassays and PCR assays that meet GLP criteria.
  • Advanced understanding of ligand binding immunoassays and analytical instrumentation ELISA, chemiluminescence/FRET/BRET/fluorescence/Bioluminescence assays development.
  • Expertise using analytical and statistical methods: Design of Experiments (DoE), ANOVA, JMP or other statistical software.
  • Experience working with human and animal tissues and biological fluids.
Preferred Qualifications
  • Experience in biomarker discovery.
  • Experience executing validation studies.
  • Experience on immunoassay platforms that may include Meso Scale Discovery (MSD), ELISA, Gyros or Quanterix.
  • A publication history in biologic drug development, bioanalytical method validations, immunoassays or molecular assays.
  • A work history that demonstrates the ability to drive the development of new products or services related to immunoassay and PCR assays.
  • Background in nanotechnology.