The Research Associate within the Process/Product Development group will support the assay development and documentation for new or existing NGS-based IVD products in a regulated environment (FDA-QSR, CLIA, CAP, ISO regulations). This role requires knowledge of molecular biology and product development bench techniques.
- Perform sample accessioning, qualification of equipment, and development activities to support FDA submission.
- Author documentation to support IVD product development under QSR design control.
- Isolates DNA/RNA from oncology specimens (such as FFPE tissue and blood samples).
- Perform standard molecular biology techniques and complex optimization experiments in the areas of Next Generation Sequencing.
- Operate complex laboratory equipment including high throughput robotic liquid handlers.
- Support execution of development, verification, and validation studies for NGS-based IVD product.
- Collaborate with other development scientists to conduct guard banding, stability studies, testing and verification for reagents and assays.
- B.S with 2 years of work experience in the life science industry.
- M.S with 0 – 1 years of work experience in the life science industry.
- Understanding of essential molecular biology methods such as PCR, library preparation for NGS, nucleic acid extraction, purification and quantification.
- Experience with IVD product development and validation under an FDA regulated environment a plus.
- Skilled at writing clear SOPs, work instructions, protocols, validation reports, and experience with Quality System Regulations (QSR) part 820 or CLIA/CAP compliant laboratory a plus.
Personalis is an Equal Opportunity Employer/Minorities/Females/Veterans/Disabilities. Personalis offers a competitive compensation package.