At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world’s most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development. Cepheid is proud to work alongside a community of six fellow Danaher Diagnostics companies. Together, we’re working at the pace of change on diagnostic tools that address the world’s biggest health challenges, driven by knowing that behind every test there is a patient waiting. Learn about the Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The R&D Staff Scientist, Global MEMP, FIT, Sustainment is responsible for planning, executing, and discussing experiments that drive product development and sustainment. As a Staff Scientist, Global MEMP, FIT, Sustainment, the employee has opportunities to learn Cepheid integrated platforms and technology with the goal of developing infectious disease tests that Cepheid has planned in its product pipeline. These activities are in support of new product development (NPD), market protection, and business continuity strategies to ensure product availability and quality as demand increases in the market(s). This position is part of the Biotechnology R&D department and will be located in Sunnyvale, CA, Onsite. Our goal as a department, and as an overall organization is to understand the needs of our customers and to respond with accessible molecular diagnostic test systems as tools to improve the health and integrity of all communities. Our department is responsible for the active design of these systems with guidance from our leadership and multidisciplinary (i.e. interdepartmental) project core teams. In this role, you will have the opportunity to: + Lead, execute, and facilitate discussions regarding critical NPD and post-launch studies. Examples of studies: + Limit of detection + Product Stability + Inclusivity/Exclusivity + FMECA + Robustness/Reliability/DFM + Precision studies (repeatability and reproducibility) + Collaborate with interdisciplinary SMEs to develop novel applications of our existing and future platforms and technology. + Drive product development by communicating and providing actionable data. + Develop yourself into a multi-subject SME via coaching from your team and the senior level Cepheid Scientific community. + Work with a proven and talented team of scientists that are dedicated to providing the best molecular diagnostic solutions to the public while responding to changes in key markets and updated regulatory guidelines. The essential requirements of the job include: + PhD (or MS/BS with equivalent experience) in a Biological Science field (e.g. Molecular Biology, Biochemistry, Bioengineering, Chemistry, Biology or related filed) with 6+ years of industry related experience or academic equivalent + Experienced in interpreting and analyzing large scale experimental data as well as results from clinical trials. + Real time PCR or RT-PCR and product development experience. + Experience in handling clinical specimens, microorganisms involved in infections diseases and be able to work in a BSL-2 environment. + Preparing and facilitating regulatory submissions to BSI, WHO, and/or country specific regulatory agencies. It would be a plus if you also possess previous experience in: + Being a part of an NPD team that has successfully launched an FDA cleared molecular diagnostic test. + Being a part of a PLM team that has successfully submitted a change notification for an FDA cleared molecular diagnostic test. + Developing data analysis tools that are integrated with a compliable database and experienced use in bioinformatic tools to assist in DOE, and clinical study design. Programs that we may use are: + Python + R + Minitab + JMP + MATLAB Cepheid, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at danaherbenefitsinfo.com. The salary range for this role is $133,000 to $207,000 USD. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. We may ultimately pay more or less than the posted range. This range may be modified in the future. This job is also eligible for bonus/incentive pay. We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law. Given the essential job duties of this position, the employee is required to be fully vaccinated against COVID-19 (including applicable boosters) as a condition of employment, subject to reasonable accommodation and applicable law. Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit www.danaher.com . Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve.Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes. The EEO posters are available here (https://www.dol.gov/agencies/ofccp/posters) . We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation. Operating Company: Cepheid