What if the work you did everyday could impact the lives of people you know? Or all of humanity? At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients. Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world-changing projects, you will do more and become more than you ever thought possible. We are hiring a Senior Scientist, with IVD expertise to work, with the Clinical Assay Development team, and to help develop robust assays based on next-generation sequencing for precision oncology. As a Study Lead, the Senior Scientist will oversee highly visible projects and complex studies by serving as a technical subject matter expert, conduct data analysis and verification for evidence needs, author reports and protocols, provide work oversight and mentorship to junior team members and troubleshoot in the lab when necessary. Collaborate with internal partners, including Quality, Regulatory, Clinical Affairs, Biostatistics, Software, Bioinformatics, Operations as well as external diagnostic technology partners to track progress of goals and deliverables, present results and propose solutions. Additional Responsibilities: Make decisions and drive ongoing improvements in functional and project teams designing, performing, troubleshooting, analyzing and presenting experiments. Accountable for team execution of IVD verification and validation protocols and writing reports for regulatory submissions. Write reports and present results, project and technology assessments to senior management and leadership. Guide technical areas independently and may lead cross functional product development projects Requirements: Senior level: PhD and 3-5 years of industry experience in biological assay development or in lieu of PhD, may consider a BSc/MS degree and 9 years of strong industry experience. Leadership: 2 years’ experience leading cross functional product development programs for genomics solutions and/or medical devices. 2 years’ developing, mentoring and leading high performing scientists; 3 years preferably specialized in nucleic acid chemistry. Ability to translate corporate goals into executable R&D plans while understanding technical risks, mitigations and alternatives. Strong background in NGS technology and data analysis tools highly desired. Experience with design transfer from development to operations is highly desirable. Experience in oncology a plus. Experience in a CLIA lab environment a plus. Proven data analysis and statistical interpretation skills of large complex genomics data sets desired. Proven record of transferring new products to manufacturing and/or QC in a fast-paced biotech environment under design control is highly desired. Firsthand experience of utilization of structured Design of Experiments (DOE) and Critical Parameter Management is preferred. Excellent oral and written communication skills required to clearly explain complex issues, progress reports and technical roadmaps to a variety of audiences across functions and levels. Keywords: Oncology, In Vitro Diagnostics (IVD), Assay Development, Next Generation Sequencing (NGS), Regulated Health, Molecular, DNA, RNA, Design of Experiment (DOE), Library Preparation, PCR, Verification and Validation (V&V) Studies, IVDR, CLSI Guidance, Precision Medicine, Genomics, Genome, Molecular Biology, Hematological Cancers, Liquid Biopsy, Solid Tumor, Companion Diagnostics (CDx), Nucleic Acid Chemistry, CLIA, Comprehensive Genomic Profiling (CGP), Design Transfer, Product Transfer All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities. Candidate will be hired into the appropriate job requisition and level commensurate with completed education and related experience. Concerns regarding COVID-19 continue as positive cases are experienced in the communities in which we operate. Please be aware that, as a condition of employment, Illumina may require proof of COVID vaccination in accordance with local statutory requirements (subject to limited exceptions) beginning November 1, 2021. At Illumina, we strive to foster a diverse and inclusive workplace by cultivating an environment in which everyone contributes to our mission. Built on a strong foundation, Illumina has always been rooted in openness, collaboration, and seeking alternative views and perspectives to propel innovation in genomics. We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race. We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and demonstrate our collective commitment to diversity and inclusion in the communities we live and work. We are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf