Scientist II, Research and Development

Thermo Fisher Scientific • Fremont, CA

1d • $79,200 - $105,600 • Onsite

About The Position

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.

Requirements

• 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 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.
• Self-motivated, proactive, and driven to ensure the efficient execution of project tasks.
• Ability to use word processing, presentation and spreadsheet software.
• Ability to present and communicate (oral and written) information in a clear manner.
• Good organization and time management skills.

Nice To Haves

• 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.
• Preferred familiarity with FDA/ISO design controls, risk management frameworks, and regulatory requirements specific to IVD products.
• 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 within the R&D team and in the greater community.

Responsibilities

• 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.
• Author robust study protocols, develop data analysis/calculation worksheets, and execute benchtop laboratory testing in strict accordance with approved protocols.
• Review experimental results to ensure absolute data accuracy; perform comprehensive data analysis, synthesize findings, provide data-driven recommendations, and author technical performance reports.
• Execute all operations in full compliance with FDA Design Controls, ISO standards, cGMP, GLP, and Good Documentation Practices (GDP).
• Manage and execute assignments with minimal supervision. Troubleshoot experimental anomalies and recommend effective corrective actions under general guidance.
• Manage contributions to multiple parallel projects effectively, maintaining a strong focus on laboratory safety, continuous improvement, and department goals.

Benefits

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement
• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level