Senior Scientist - Immunoassay and PCR

Early is Good is a cancer-focused company based in Indianapolis, dedicated to advancing healthcare through innovative multi-omics solutions. We develop highly accurate, non-invasive tests to detect and monitor cancer, with a special focus on urologic cancers. Our lab at 16 Tech Innovation District in Indianapolis collaborates with leading institutions like Mayo Clinic, Washington University, and Indiana University.Our breakthrough Multi-omic Integration Platform combines the detection of DNA, RNA, protein and metabolite targets into a single assay. This breakthrough approach transforms the field of molecular diagnostics by offering unparalleled accuracy with comprehensive insights for early disease detection.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.Role overview 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 DNARNA 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 youMust 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 bloodurine-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, chemiluminescenceFRETBRET fluorescenceBioluminescence 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 . We look forward to hearing from you.

Created: 2024-11-02