Job Title: Research & Development – Scientist II
Location: Fremont, CA
Contract Duration: 12 months
Schedule: Monday–Friday,1st shift
Pay rate: $35- $40/hr. on W2
 
Job Description:
Position Summary:
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.
 
Main Responsibilities:

• 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.

 
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.

#sczr2