Senior Scientist, Assay Development (Diagnostics & Biophysics)

About IRIS Kinetics IRIS Kinetics is pioneering a new class of label-free biosensing platforms for next-generation diagnostics and life sciences. Our technology enables ultra-sensitive, real-time measurement of biomolecular interactions to accelerate discovery and transform patient testing. We are seeking a Senior Scientist to lead our assay development efforts for diagnostic and clinical applications, advancing the IRIS platform from research to clinical readiness. Position Overview The Senior Scientist will be responsible for developing, optimizing, and validating immunoassays and molecular assays on the IRIS platform. This individual will serve as the technical lead bridging assay development with product engineering and commercialization teams, ensuring robust analytical performance and regulatory readiness. Key Responsibilities Lead design and optimization of assays for detection of proteins, antibodies, nucleic acids, and small molecules across multiple applications. Develop and validate assay workflows using multiple methodologies including ELISA, MSD, BLI, SPR , and other immunoassay or biophysical platforms. Translate assay formats to the IRIS biosensor platform, establishing performance benchmarks for sensitivity, specificity, precision, and reproducibility. Design experiments to evaluate kinetics (kon, koff, KD), limits of detection, and matrix effects. Oversee conjugation, immobilization, and surface functionalization/spotting strategies for antibodies, antigens, and nucleic acids. Develop analytical verification and validation plans aligned with regulatory and FDA submission requirements. Collaborate closely with engineering to integrate assay workflows into hardware and software design. Mentor and guide junior scientists and associates, fostering a culture of technical excellence and innovation. Contribute to publications, grant applications, and investor-facing technical documentation supporting product and fundraising milestones. Qualifications Required Ph.D. or M.S. in Biochemistry, Molecular Biology, Biophysics, Biomedical Engineering, or related field. 5+ years of industry experience developing assays for IVD or life science platforms . Proven expertise in immunoassay development and characterization of antigen–antibody interactions. Hands‑on experience with one or more label‑free biosensing technologies (BLI, SPR, QCM) and conventional assays (ELISA, MSD, etc.). Strong understanding of conjugation and surface functionalization chemistry (protein coupling, spotting, immobilization). Familiarity with diagnostic product development , including verification/validation and regulatory submission (FDA, CLIA, or CE‑IVD). Demonstrated ability to design and execute experiments independently, analyze data, and communicate results clearly. Preferred Experience with multiplexed assays and biosensor‑based diagnostic products. Prior involvement in FDA submission or regulatory documentation for diagnostic assays. Leadership experience mentoring teams and cross‑functional collaboration in a fast‑paced environment. Ability to balance high‑level strategy with hands‑on experimental work. What We Offer A chance to lead assay development on a cutting‑edge diagnostic platform. High‑impact work bridging science, engineering, and product development. Competitive compensation, benefits, and growth opportunity toward leadership roles. Ideal Candidate Snapshot You are a hands‑on assay development leader who has been there before and developed, optimized, validated, and delivered diagnostic assays that made it into real products. You bring scientific rigor, creativity, and structure to an early‑stage startup environment and are excited to help translate breakthrough biosensor technology into the next generation of diagnostics. For your application to be considered, please send a short note to the hiring manager or View email address on click.appcast.io briefly describing one diagnostic assay you personally led from development through validation. What was the modality, target, LoD, and where did it land (RUO, FDA submission, product launch)? #J-18808-Ljbffr IRIS Kinetics