Staff Scientist IVD Development

Employment Type

: Full-Time

Industry

: Miscellaneous



Responsibilities: * Create and execute protocols for IVD product development * Lead cross functional product development projects and guide technical areas independently * Be accountable for team execution of IVD verification and validation protocols and writing reports for regulatory submissions * Manage goals, budgets and resources within defined target timeframes and make decisions regarding the goals and progress of project / functional teams * Technically and personally mentor and develop a team of scientist, research associates and automation specialist to commercialize best in class array products * Perform equally well as a collaborative team leader and proactive functional manager as well as a strong scientific individual contributor depending on project needs; be highly adaptive to changing project scopes and responsibilities * Have a good working knowledge of IVD product requirements and clinical laboratory workflows and needs * Make decisions and drive on going improvements in functional and project teams designing, performing, troubleshooting, analyzing and presenting of experiments * Write reports and present results, project and technology assessments to Senior Management to enable them to make informed business decisions Requirements: * Ability to translate corporate goals into executable R&D plans while understanding technical risks, mitigations and alternatives * Proven record of transferring new products to manufacturing and/or QC in a fast-paced biotech environment under design control. Including numerous examples of utilization of structured Design of Experiments (DOE) and Critical Parameter Management highly desired * Strong background in NGS technology * Highly motivated, detailed individual with the proven ability to think innovatively toward solving technical and structural problems effectively and efficiently * Able to work effectively under pressure to meet scheduled deadlines and handle multiple activities simultaneously * Proven data analysis and statistical interpretation skills of large complex genomics data sets desired * 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 * Experience in oncology a plus * Experience in a CLIA lab environment a plus Experience/Education: * Typically requires a Ph.D. with 3 years' related experience; or equivalent work & educational experience. * 2+ years' experience leading cross functional product development programs for genomics solutions and or medical devices * 2+ years' experience developing, mentoring and leading high performing scientists and RA in a functional management role All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities 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

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