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Senior Scientist – Immunoassay and PCR
1 month ago
Early is Good is a pioneering cancer-focused company based in Indianapolis, dedicated to revolutionizing healthcare through cutting-edge multi-omics solutions. Our mission is to develop highly accurate, non-invasive tests to detect and monitor cancer, with a special focus on urologic cancers.
Job OverviewWe're seeking a highly skilled and passionate scientist to join our Assay Product Development team. As a key member of our team, you will be responsible for driving the advancement of our proprietary nanotechnology multi-omics assay portfolio. Your expertise will be crucial in all stages of development, from optimization and validation to commercialization.
Key Responsibilities- Design, execute, and analyze experiments to support late-phase development activities for DNA/RNA and protein Immunoassays on various biological specimens.
- Provide technical expertise for immunoassay and PCR development activities, including assay development, optimization, calibrator and control evaluations, design verification, and validation.
- Plan and execute development activities, execute experiments and studies, and document results within a design change control environment in accordance with 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.
- 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, including 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.
- Expertise using analytical and statistical methods, including Design of Experiments (DoE), ANOVA, and JMP or other statistical software.
- Experience in biomarker discovery.
- Experience executing validation studies.
- Experience on immunoassay platforms, including 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 demonstrating the ability to drive the development of new products or services related to immunoassay and PCR assays.
We offer a competitive salary and benefits package. If you have any questions about the job, please send an email to hl@earlyisgood.com. We look forward to hearing from you.