Senior Scientist Assay Development 1

EPM Scientific; Hayward (CA); On-site; USD 110,000 - 170,000; Full time

Job summary

EPM Scientific seeks a Senior Scientist I to lead design, development, optimization, and validation of IVD assays for clinical applications. This role requires hands-on lab work, regulatory compliance, and cross‑functional collaboration to drive product development and commercialization.

The incumbent will contribute to FDA/regulatory submissions, implement QC measures, and mentor junior staff while advancing assay technology in a fast-paced environment.

Qualifications

• Ph.D. or M.S. in Biochemistry, Molecular Biology, Immunology, or related fields.
• 5+ years in IVD assay development and validation; hands-on immunoassay and/or molecular techniques.
• Strong knowledge of regulatory frameworks (FDA 21 CFR Part 820, ISO 13485).
• Proficiency in data analysis tools (Excel, GraphPad Prism, or statistical software).

Responsibilities

• Develop IVD assays for FDA and global approvals/clearances.
• Design and execute experiments to develop assays and establish performance specifications.
• Optimize and troubleshoot assays to meet performance targets.
• Transfer assay designs to tech transfer and manufacturing; define QC measures and scale-up support.
• Collaborate with Quality, Regulatory, Engineering, Product Management, Tech Transfer, and Manufacturing to meet milestones.
• Participate in technical discussions and project meetings.
• Design and execute V&V studies and document results for regulatory review.
• Perform data analysis and generate study reports for regulatory submissions.
• Identify issues, propose solutions, and drive assay/process improvements.
• Stay current with literature and evaluate emerging technologies.

Skills

IVD assay development

immunoassay formats

molecular techniques

regulatory knowledge

data analysis tools

Education

Ph.D. in Biochemistry/Molecular Biology/Immunology or related

M.S. in Biochemistry/Molecular Biology/Immunology or related

Tools

Excel

GraphPad Prism

Job description

Position Summary

The Senior Scientist I - IVD Assay Development will lead the design, development, optimization, and validation of in vitro diagnostic assays for clinical applications. This role requires hands‑on laboratory work, regulatory compliance, and cross‑functional collaboration to ensure successful product development and commercialization.

Duties and 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 Quality, Regulatory Affairs, Engineering, Product Management, Tech Transfer, and Manufacturing to meet program milestones and commercialization readiness
• Participate in technical discussions and project meetings
• Design and execute 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

Qualifications

• * 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), and/or 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)

Please Note

We participate in E-Verify to confirm authorization to work in the United States.