Senior Scientist, IVD Assay Development

Alamarbiosciences; Fremont (CA); On-site; USD 150,000 - 165,000; Full time

Benefits offered by this job

Bonus

Equity

Benefits

Job summary

Alamarbiosciences is seeking a Senior Scientist I - IVD Assay Development in Fremont, California. You will lead the design, development, optimization, and validation of in vitro diagnostic assays for clinical applications.

This position requires substantial laboratory work and collaboration with cross-functional teams to ensure successful product development. Ideal candidates have a strong background in IVD assay development, including regulatory frameworks and data analysis tools.

The base salary range for this full-time position is $150,000 - $165,000, along with bonuses, equity, and benefits.

Qualifications

• 5+ years in IVD assay development and validation.
• Hands-on experience with immunoassay formats (ELISA, chemiluminescent), and/or molecular techniques (qPCR, sequencing).
• Strong knowledge of regulatory frameworks (FDA 21 CFR Part 820, ISO 13485).

Responsibilities

• Develop IVD assays for FDA and other global regulatory approval/clearance.
• Optimize and troubleshoot assays to meet performance expectations.
• Participate in technical discussions and project meetings.

Skills

IVD assay development

Regulatory compliance

Immunoassay formats

Data analysis tools

Education

Ph.D. or M.S. in Biochemistry, Molecular Biology, Immunology or related fields

Tools

Excel

GraphPad Prism

Job description

Alamarbiosciences is seeking a Senior Scientist I - IVD Assay Development in Fremont, California. You will lead the design, development, optimization, and validation of in vitro diagnostic assays for clinical applications.

This position requires substantial laboratory work and collaboration with cross-functional teams to ensure successful product development. Ideal candidates have a strong background in IVD assay development, including regulatory frameworks and data analysis tools.

The base salary range for this full-time position is $150,000 - $165,000, along with bonuses, equity, and benefits.