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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
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
Required
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
- Phone Screen
- Virtual or Onsite Interview
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
- 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
- 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
- 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
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
- 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
- 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