Personalis is a rapidly growing cancer genomics company transforming the development of next-generation therapies by providing more comprehensive molecular data about each patient’s cancer and immune response. Our ImmunoID NeXT Platform® is enabling the development of next generation immuno-oncology therapeutics and diagnostics.
The Senior 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 a broad knowledge of molecular biology and product development bench techniques.
Support execution of development, verification, and validation studies for NGS-based IVD product.
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.
Collaborate with other development scientists to conduct guard banding, stability studies, testing and verification for reagents and assays.
Design experiments for process characterization, performance qualification of equipment, and development activities to support FDA submission.
B.S with 3 - 5 years of work experience in the life science industry.
M.S with 2 years of work experience in the life science industry.
Experience with IVD product development and validation under an FDA regulated environment.
Understanding of essential molecular biology methods such as PCR, library preparation for NGS, nucleic acid extraction, purification and quantification.
Skilled at writing clear SOPs, work instructions, protocols, validation reports, and experience with Quality System Regulations (QSR) part 820 or CLIA/CAP compliant laboratory.
**We have multiple openings for this position, one application is sufficient.**
Personalis is an Equal Opportunity Employer/Minorities/Females/Veterans/Disabilities. Personalis offers a competitive compensation package.