Senior Scientist, Assay Development (Diagnostics & Biophysics) jobs in United States
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IRIS Kinetics · 1 month ago

Senior Scientist, Assay Development (Diagnostics & Biophysics)

IRIS Kinetics is pioneering a new class of label-free biosensing platforms for next-generation diagnostics and life sciences. They are seeking a Senior Scientist to lead assay development efforts for diagnostic and clinical applications, ensuring robust analytical performance and regulatory readiness.

Biotechnology

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

Qualification

Immunoassay developmentLabel-free biosensing technologiesConjugation chemistryDiagnostic product developmentExperiment designExecutionMentoring teamsCross-functional collaborationCommunication skills

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 fast-paced environments
Ability to balance high-level strategy with hands-on experimental work

Benefits

Competitive compensation
Benefits
Growth opportunity toward leadership roles

Company

IRIS Kinetics

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At iRiS Kinetics, we are pioneering the future of molecular interaction analysis with instrumentation designed for the label-free detection of biomolecular binding.

Funding

Current Stage
Early Stage

Leadership Team

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Selim Unlu
Founder and CEO
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Claude Dufresne
Chief Commercial Officer (CCO)
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Company data provided by crunchbase