Scientist II

Our client, a world leader in life sciences and biotechnology, is looking for a “Scientist II” based out of Santa Clara, CA.

We are seeking a Scientist to join the Assay Development team supporting the development of RUO and CE -IVD/IVD products for next -generation sequencing (NGS) platforms. This role will focus on assay development, optimization, validation, and execution of molecular biology workflows within a design -controlled environment.

• Design, execute, and troubleshoot laboratory experiments related to NGS assay development.
  
• Perform molecular biology techniques including PCR, qPCR, nucleic acid extraction, target enrichment, and library preparation.
  
• Support assay optimization, characterization, reagent selection, and validation activities.
  
• Operate automated liquid handling systems and sequencing instrumentation.
  
• Analyze experimental data and prepare technical summaries, reports, and presentations.
  
• Maintain accurate laboratory documentation, SOPs, and Design History File (DHF) records.
  
• Support design control, verification, and validation activities in compliance with ISO 13485 and quality system requirements.
  
• Participate in reagent preparation, inventory management, equipment maintenance, and laboratory operations.
  

• Bachelor’s degree in Molecular Biology, Biological Sciences, Biochemistry, Chemistry, or related field; Master’s degree preferred.
  
• 5+ years of laboratory experience (less with advanced degree) in molecular biology, assay development, or NGS applications.
  
• Hands -on experience with PCR, qPCR, nucleic acid extraction, library preparation, and NGS workflows.
  
• Experience with assay development, optimization, validation, and troubleshooting.
  
• Familiarity with automated liquid handling platforms (Hamilton, Tecan, Bravo, etc.) and sequencing instruments.
  
• Strong data analysis, documentation, and technical writing skills.
  
• Experience working in regulated environments with ISO 13485, design controls, SOPs, and DHF documentation preferred.
  
• Excellent communication and collaboration skills.
  

• Knowledge of NGS target enrichment workflows.
  
• Experience with statistical analysis tools such as JMP, R, or Python.
  
• Prior experience supporting IVD, molecular diagnostics, or genomics product development.