Bioinformatics Scientist II

We are seeking an exceptionally talented Bioinformatics Scientist to join our Sustaining and Continuous Improvement group within Global Operations, responsible for building, updating, and monitoring robust QC processes for microarray and NGS-based high-volume LDT diagnostic products—primarily RNA-based—run in CLIA labs. This role oversees daily activities that ensure operational excellence, drives process improvements, and supports troubleshooting with cross-functional teams. The successful candidate will help maintain consistent product performance through routine CLIA updates, contribute to verification and validation plans and documentation, and participate in design reviews. Working in a highly collaborative, well-supported environment, this individual will gain valuable experience in diagnostic product development and sustaining while seeing their contributions rapidly translated into products that improve patient lives.

Key Responsibilities

• Bioinformatic analysis using existing computational biology knowledge and tools, as well as developing and implementing novel algorithmic biological approaches, and deriving the most relevant genomic information to answer key bioinformatic questions in laboratory performance.
• Evaluate technical variability and monitor robust quality control (QC) processes for NGS-based high-volume Laboratory Developed Test (LDT) disease diagnostic products run in CLIA labs, with a primary focus on RNA-based assays.
• Help to develop and author SOPs, experimental protocols, and technical reports related to experimental studies that become part of the Design History Files and regulatory filings.
• Interact seamlessly with multi-disciplinary teams such as the CLIA operations, Customer Care, R&D, and Quality to implement process improvements and to identify root cause of in-service problems.
• Troubleshoot and solve technical challenges that arise during the development process and routine operations.
• Implement data visualizations using Tableau or other tools to proactively identify trends in the production laboratory.

• A Master’s or Ph.D. in Bioinformatics, Computational Biology, or related field of study.
• Minimum of 2 years (Ph.D.) or 4 years (M.Sc.) of relevant work experience, with demonstrated expertise in working with high-throughput
• Working knowledge of genomics and molecular biology.
• Strong analytical skills and demonstrated proficiency in programming languages such as R, and/or Python. Experience in data visualization, data wrangling, and SQL is required. The candidate should have hands-on experience with high-dimensional data and cutting-edge bioinformatics pipelines.
• Comfort with Linux-based operating systems and good software engineering practices including maintaining code via version controlled systems (e.g., GitHub, Bitbucket).
• Experience with AWS Services, S3, EC2.
• Experience in building R shiny apps or data dashboards with BI tools such as Tableau.
• Excellent written and verbal communication and presentation skills are required. Ability to translate complex computational concepts in such a way that scientifically trained individuals in other disciplines can readily understand their significance.
• In addition, it is highly desirable if you will bring the following experience and expertise with you:
  • Prior experience working with clinical tests in a regulated environment (i.e., CAP, CLIA, NYS, ISO 15189, ISO13485).
  • Working experience in regulated diagnostic assay development.

#LI-Onsite, #LI-Hybrid, or #LI-Remote

SALARY RANGE in San Diego $119,000 - $167,000

SALARY RANGE in South San Francisco $152,000 - $170,0000