Scientist II

Job Description

Job Summary:

• Client Diagnostics within the Clinical Diagnostics Division of Client is seeking a highly motivated, innovative and experienced professional to join the Research and Development department at Fremont, California.
• This is a hands-on, bench-based scientist role primarily responsible for supporting analytical performance verification activities for our In Vitro Diagnostic (IVD) immunoassay products.
• The generation of these experimental results will directly support the compilation of technical performance chapters for regulatory dossiers, ensuring compliance with the European Union’s In Vitro Diagnostic Regulation (IVDR).
• 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.

Duties and Responsibilities:

1. 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.

2. Protocol Development: 

• Author robust study protocols, develop data analysis/calculation worksheets, and execute benchtop laboratory testing in strict accordance with approved protocols.

3. 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.

4. Regulatory Compliance: 

• Execute all operations in full compliance with FDA Design Controls, ISO standards, cGMP, GLP, and Good Documentation Practices (GDP).

5. Independent Problem Solving: 

• Manage and execute assignments with minimal supervision. Troubleshoot experimental anomalies and recommend effective corrective actions under general guidance.

6. Cross-Functional Support: 

• Manage contributions to multiple parallel projects effectively, maintaining a strong focus on laboratory safety, continuous improvement, and department goals.

Education:

• Minimum Requirements: Bachelor’s degree in chemistry, biochemistry, molecular biology, immunology, microbiology, bioengineering or related life sciences discipline.
• Preferred Qualifications: Advanced degree (Master’s or Ph.D.) is a plus.

Experience:

• 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 within the R&D team and in the greater community.
• 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.