Senior Scientist I, IVD Assay Development at Alamar Biosciences

Fremont, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Diagnostics, Medical DevicesIndustries

Requirements

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

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

Skills

IVD assay development

FDA regulatory compliance

assay optimization

troubleshooting

verification and validation

data analysis

QC measures

tech transfer

manufacturing scale-up

sensitivity analysis

specificity testing

reproducibility testing

Alamar Biosciences

Develops technology for protein detection and measurement

About Alamar Biosciences

Alamar Biosciences focuses on the study of proteins, known as proteomics, to enhance disease detection and treatment. The company has created NULISA™, a technology that can detect and measure proteins in the human body with high sensitivity and a wide range. This allows researchers and clinicians to profile clinically relevant protein biomarkers, which are essential for developing new diagnostic tests and treatments for various diseases. Alamar's ARGO™ system complements NULISA™ by providing a fully automated, high-throughput platform for precision proteomics. Unlike competitors, Alamar's technology simplifies the process, reducing the need for extensive technical expertise, making it more accessible to clients. The goal of Alamar Biosciences is to improve our understanding of proteins in health and disease, ultimately leading to better early detection and treatment options.

Hayward, CaliforniaHeadquarters

2018Year Founded

$225.7MTotal Funding

GRANTCompany Stage

Biotechnology, HealthcareIndustries

51-200Employees

Benefits

401(k) Company Match

401(k) Retirement Plan

Performance Bonus

Company Equity

Risks

Increased competition from Olink and SomaLogic may impact Alamar's market share.

Scaling production in Europe and APAC could strain resources and affect quality.

Regulatory hurdles in new regions may delay product launches and affect revenue.

Differentiation

Alamar's NULISA™ technology offers unprecedented sensitivity in protein detection.

The ARGO™ system automates high-throughput proteomics, reducing the need for technical expertise.

Alamar's focus on early disease detection sets it apart in the biotechnology field.

Upsides

ISO 13485:2016 certification boosts Alamar's credibility in the medical device industry.

European expansion with Milan headquarters enhances market reach and client service.

$10M investment accelerates Alzheimer's diagnostics development, strengthening Alamar's market position.

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