Scientist II, Research and Development

Work Schedule Standard (Mon-Fri) Environmental Conditions Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description When you join us at Thermo Fisher Scientific, you’ll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $22 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world. Location/Division Specific Information Clinical Diagnostics Division/Niche Diagnostics This is an on-site position located in Fremont, CA. How will you make an impact? Niche Diagnostics within the Clinical Diagnostics Division of Thermo Fisher Scientific is seeking a highly motivated, innovative and experienced professional to join the Research and Development department at Fremont, California. The R&D Scientist II position is a hands-on bench position within the Applications Team responsible for supporting analytical performance studies for our In Vitro Diagnostic (IVD) immunoassay products to support the launch of new assay applications. The ideal candidate shall have excellent hands-on lab skills, strong documentation skills, demonstrated ability to analyze and interpret data to draw conclusions and make recommendations, and strong collaboration and teamwork skills.

Study Design & Execution: Design and conduct rigorous analytical performance verification studies (e.g., accuracy, precision, sensitivity, linearity, specificity, interference, and stability) in alignment with CLSI guidelines and recognized industry standards. Protocol Development: Author robust study protocols, develop data analysis/calculation worksheets, and execute benchtop laboratory testing in strict accordance with approved protocols. Data Analysis & Reporting: Review experimental results to ensure absolute data accuracy; perform comprehensive data analysis, synthesize findings, provide data-driven recommendations, and author technical performance reports. Regulatory Compliance: Execute all operations in full compliance with FDA Design Controls, ISO standards, cGMP, GLP, and Good Documentation Practices (GDP). Independent Problem Solving: Manage and execute assignments with minimal supervision. Troubleshoot experimental anomalies and recommend effective corrective actions under general guidance. Cross-Functional Support: Manage contributions to multiple parallel projects effectively, maintaining a strong focus on laboratory safety, continuous improvement, and department goals.

Bachelor’s degree in chemistry, biochemistry, molecular biology, immunology, microbiology, bioengineering or related life sciences discipline.

2-3+ years of hands-on, lab-based experience in an industrial setting, or an equivalent combination of academic and research experience. Strong knowledge of and practical experience with immunoassay techniques and antibody-based technologies is highly desirable. Familiarity with FDA-regulated environments, including knowledge of design controls, risk management, and medical device/diagnostic compliance requirements, is a plus. Direct experience with the development, verification, or validation of assays for Therapeutic Drug Monitoring (TDM), infectious disease, toxicology, QC controls, or companion diagnostics is a plus. Knowledge, Skills, Abilities: Preferred familiarity with FDA/ISO design controls, risk management frameworks, and regulatory requirements specific to IVD products. Strong hands-on laboratory skills are required, along with a genuine enthusiasm for bench-scale execution. Must be willing to take technical direction from Senior Scientists and Project Leads. Experience handling biological materials is highly desirable. Must be highly collaborative; could work within a diverse team and contribute to a supportive, positive work environment both