We're looking for a passionate, results-driven scientist committed to early cancer detection. If you thrive in fast-paced environments, uphold high ethical standards, and are eager to shape the future of cancer care, we'd love to hear from you.
This is a key role on our Assay Product Development team and your responsibility will be to drive the advancement of our proprietary nanotechnology multi-omics assay portfolio. You will be involved in all stages from development, optimization and validation.
You must have at least 5 years of industry experience in immunoassay development and a strong desire to develop and commercialize best-in-class ultrasensitive immunoassays for oncology diseases. You should be a self-starter, adaptable, and action-driven, capable of thriving in a fast-paced environment.
Key responsibilities
Creating, coordinating, and executing experiments to support late-phase development activities for DNA/RNA and protein Immunoassays on various types of biological specimens.
Providing technical expertise for immunoassay and PCR development activities, including assay development, optimization, calibrator and control evaluations, design verification and validation.
Planning development activities, executing experiments and studies, and documenting results within a design change control environment in accordance with appropriate regulatory guidelines.
Applying 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.
Developing conclusions and effectively communicating results to both internal and external audiences.
Documentation skills that will hold up to the scrutiny of a regulatory agency.
About you
Must have:
Based on level of education; MS eight (8+) years of experience and PhD (5+) or more years of experience as a scientist in clinical molecular diagnostic assays.
A work history that includes previous employment in the pharmaceutical, biotechnology, CRO (Contract Research Organization) or animal health industries
Experience with assay development in blood/urine-based immunoassays.
Have 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.
Nice to have:
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.
We offer a competitive salary & benefits package. If you have any questions about the job, please send an email to [email protected]. We look forward to hearing from you.