Scientist II

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 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