As a Senior Scientist within the Reagent Manufacturing and Quality team, you will be an integral part of Genomic Health’s Operations group, with responsibility for the development, validation, and transfer of new manufacturing processes and quality control test methods, both for new products and our existing genomic tests. In this role, you will lead and participate in cross functional teams contributing to the development of IVD and LDT products under design control, in accordance with ISO 13485 and Good Manufacturing and Laboratory Practices (GMP/GLP). You will participate in requirements definition, risk analysis, reagent and QC method development, manufacturing development and scale-up, optimization, troubleshooting, and verification and validation activities related to manufacturing and quality control testing.
The high complexity nature of the work demands in-depth understanding of reagent and consumable development, manufacturing, and analytical and functional test methods for quality control, and strong working knowledge of ISO 13485 and other applicable quality system requirements. This position requires excellent leadership, collaboration, written and verbal communication skills, attention to detail, ability to multi-task, and flexibility to adapt to changes in priority and schedules are essential.
Genomic Health is a global provider of genomic-based diagnostic tests that address the overtreatment of cancer, one of the greatest issues in healthcare today. Our goal is to improve the lives of people with cancer by providing personalized, biological information that helps them get the right treatment at the right time, and to avoid unnecessary treatments and their side effects. In this way, our work is truly life, changing.
Join the Genomic Health Team, and have the unique opportunity to make a difference in the lives of patients with cancer, while developing your career potential. We embrace our unique culture characterized by our Core Values of Community, Truth Seeking, Being Ahead of the Curve and Winning to be the best in the world at what we do. We maintain competitive total rewards programs designed to satisfy our employees’ work life and personal life needs.
All qualified applicants will receive consideration for employment without regard to race, sex, gender identity, color, religion, national origin, protected veteran status, or on the basis of disability.