Lead IVD Assay Development Scientist

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

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.