No sub-contracting, NO sponsorship or transfers! Be local to NorCal Bay area as this is onsite full time !!

JD:

Scientist Assay Development (NGS Product Development)

Location

Santa Clara, CA
Onsite Position

Interview Process

1. Phone Screen
2. Virtual or Onsite Interview

Position Overview

We are seeking a Scientist Contractor 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 contribute to the design, development, optimization, and validation of molecular assays and workflows in a regulated, design-controlled environment.

The ideal candidate will bring strong hands-on molecular biology expertise, experience with NGS workflows, and the ability to independently execute laboratory experiments while maintaining high-quality documentation and compliance standards.

Key Responsibilities

Laboratory Execution & Assay Development

• Independently plan and execute laboratory experiments under the guidance of functional leadership with strong attention to detail and scientific rigor
• Design and perform assay development studies including optimization, troubleshooting, reagent evaluation, assay characterization, and workflow improvements
• Contribute to development activities involving nucleic acid extraction, PCR/qPCR, library preparation, target enrichment, sequencing workflows, and data analysis
• Recommend experimental approaches and study plans based on scientific findings and project objectives
• Prepare reagents, buffers, and testing materials according to SOPs
• Operate automated liquid handling systems and sequencing instrumentation
• Ensure timely completion of experiments while adapting to shifting project priorities

Data Analysis & Documentation

• Accurately document experimental procedures, materials, and results in electronic or paper laboratory notebooks
• Analyze experimental data using established tools and summarize findings clearly and effectively
• Present project updates and technical findings during internal team and departmental meetings
• Prepare technical summaries and contribute to verification reports and supporting documentation
• Assist with drafting and updating SOPs, protocols, and technical documents
• Maintain material traceability and documentation within a design-controlled environment
• Support Design History File (DHF) documentation activities

Quality & Compliance

• Perform all activities in compliance with ISO 13485, QSR, OSHA, and internal quality system requirements
• Participate in design control and quality documentation activities as assigned
• Ensure accuracy, consistency, and integrity of experimental results and records
• Follow laboratory safety procedures and best practices

Laboratory Operations

• Support routine maintenance and organization of laboratory spaces
• Maintain laboratory equipment and assist with calibration activities
• Monitor reagent and consumable inventory and ensure proper storage conditions
• Collaborate with cross-functional teams by providing experimental support and data as needed

Qualifications

Required

• Bachelor s degree in Molecular Biology, Biological Sciences, Biochemistry, Chemistry, or related discipline
• Minimum 5+ years of relevant laboratory experience with a Bachelor s degree (less experience required with advanced degrees)
• Strong hands-on molecular biology laboratory skills and proficient manual pipetting techniques
• Experience with PCR, qPCR, nucleic acid extraction, and NGS library preparation
• Strong data analysis, technical documentation, and organizational skills
• Ability to work effectively in a collaborative team environment with strong communication skills

Preferred

• Master s or PhD in a related scientific discipline
• Experience with assay design, optimization, and validation
• Knowledge of NGS workflows including target enrichment and sequencing library preparation
• Experience working in regulated or design-controlled environments supporting IVD or diagnostic product development
• Familiarity with automated liquid handling systems and sequencing platforms

What We re Looking For

• A detail-oriented scientist who thrives in a hands-on laboratory environment
• Strong problem-solving and troubleshooting capabilities
• Ability to balance scientific rigor with execution speed in a fast-paced R&D setting
• A collaborative team player who can communicate effectively across functional groups