Senior Scientist I, IVD Assay Development jobs in United States
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Alamar Biosciences, Inc. · 15 hours ago

Senior Scientist I, IVD Assay Development

positionFremont, California
timeFull-time
remoteOnsite
senioritySenior Level
money$140K/yr - $165K/yr
date5+ years exp

Alamar Biosciences is dedicated to enabling scientific discoveries that translate into clinical outcomes. The IVD Assay Development Senior Scientist I will lead the design, development, optimization, and validation of in vitro diagnostic assays for clinical applications, requiring hands-on laboratory work and cross-functional collaboration.

BiotechnologyHealth CareMedical
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H1B Sponsor Likelynote

Responsibilities

Develop IVD assays for FDA and other global regulatory approval/clearance
Design and execute experiments to develop IVD assays and establish assay performance specifications (sensitivity, specificity, reproducibility)
Optimize and troubleshoot assays to meet performance expectations
Transfer assay designs to tech transfer and manufacturing; define QC measures and support scale-up activities
Work closely with R&D, Quality, Regulatory Affairs, and Engineering teams
Participate in technical discussions and project meetings
Design and execution of verification and validation (V&V) studies, including all testing and documentation
Perform data analysis and generate study reports suitable for regulatory review
Identify and troubleshoot assay or process issues, recommend solutions, and contribute ideas for assay and process improvements
Stay current on relevant technological and scientific advancements through literature review and evaluation of emerging technologies
Perform other duties as required

Qualification

IVD assay developmentRegulatory complianceImmunoassay formatsData analysis toolsMolecular techniquesCommunication skillsDocumentation skills

Required

Ph.D. or M.S. in Biochemistry, Molecular Biology, Immunology, or related fields
5+ years in IVD assay development and validation
Hands-on experience with immunoassay formats (ELISA, chemiluminescent), enzymatic assays, and molecular techniques (qPCR, sequencing)
Strong knowledge of regulatory frameworks (FDA 21 CFR Part 820, ISO 13485)
Proficiency in data analysis tools (Excel, GraphPad Prism, or statistical software)
Excellent documentation and communication skills

Benefits

Bonus
Equity
Benefits

Company

Alamar Biosciences, Inc.

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Alamar Biosciences is powering precision proteomics with automated, high throughput solutions for ultra-high sensitivity protein analysis across a range of multiplex levels.
dateFounded in 2018
location
Fremont, California, USA
people-size51-200 employees
web-link
https://alamarbio.com/

H1B Sponsorship

Alamar Biosciences, Inc. has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2024 (6)
2023 (4)
2022 (3)
2021 (3)

Funding

Current Stage
Growth Stage
Total Funding
$232M
Key Investors
Alzheimer's Drug Discovery FoundationSands Capital VenturesSherpa Healthcare Partners
2025-01-08Grant· $10M
2024-02-26Series C· $128M
2021-09-08Series B· $80M

Leadership Team

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Yuling Luo
Founder, Chairman & CEO
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Yiyuan Yin
Co-founder and VP of Technology
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Recent News

GlobeNewswire
Global Alzheimer’s Platform Foundation Announces Strategic Collaboration and Partnership with Alamar Biosciences for the Transformative Bio-Hermes Studies
2026-01-11
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2026-01-07
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Mice Model Market Size Worth USD 19.36 Billion by 2034
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Company data provided by crunchbase