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Scientist I, PCR Assay Development Oncology RD

  • Anywhere

Company :
Leica Biosystems

Location :
Sunnyvale, California

Expiry Date :
Tue, 06 Apr 2021 23:59:59 GMT

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Description :
At Cepheid, we are passionate about improving healthcare through faster, more accurate diagnostic tests. With our GeneXpert System, we ve taken the most sophisticated molecular technology and packaged it into an automated, easy-to-use format that has quickly become the platform of choice worldwide. From the largest laboratories to small physician offices, our game-changing solution delivers critical answers when clinicians and patients need them most. Through strong molecular biology capabilities and ongoing product innovation, we are focused on developing tests for healthcare-associated infections, sexual health, critical infectious disease, virology, and oncology applications. Come join our vision for a better way and help make life better for us all! For more details, visit us at or follow us on Twitter (@CepheidNews). Are you an experienced problem solving bench scientist with PCR assay product development experience for medical devices or IVD diagnostics? This job is perfect fit for you!! Join us as we are rapidly growing!! This position is in the Oncology R&D group is primarily a bench-level job focused on real-time PCR assay and product development in an FDA-QSR and ISO13485 compliant organization. The ideal candidate will have experience in general molecular biology methods such as nucleic acid extraction and real-time PCR (including primers and probe design). This candidate will be involved in all aspects of assay development, including design of nucleic acid isolation methods from different sample types such as FFPE tissues and plasma, design of highly multiplexed, real-time PCR and RT-PCR assays, the creation and validation of test methods, system integration, hands-on work at the bench as well as guiding others to meeting timelines successfully. In addition to technical qualifications, the ideal candidate will be highly goal-oriented, inquisitive, organized, and able to thrive in an atmosphere of shifting demands and priorities. The candidate should possess excellent oral and written communication skills. The ability to solve complex problems and work in a cross-functional team-based environment is a requirement. Essential job responsibilities: * Develop novel and/or improve existing Oncology IVD and/or custom real-time PCR assays following Cepheid s Design and Development guidelines. * Apply systematic approaches in problem analysis and resolution processes for project advancement. Anticipate potential problems with preventative solutions for troubleshooting. * Identify and define strategic approach to experimentation and develop alternative strategies when needed * Establish product specifications for manufacturing and product claims. * Maintain detailed experimental records and documents results in a technical report in a laboratory notebook. * Analyze data using statistical tools such as Microsoft Excel, Minitab or JMP. * Present data at internal technical meetings and data review * Follow product development lifecycle process and design control. * Plan, direct and execute development strategies independently to meet CE-IVD, FDA (510(k) and/or PMA), and other regulatory agency requirements. Training responsibilities and other requirement: * Complete all assigned and required training satisfactorily and on time * Fulfill HBV vaccination requirement by providing record of vaccination or agree to complete the dosing schedule after onboarding Minimum requirements * PhD (or MS/BS with equivalent experience) in relevant field – e.g. Molecular Biology, Biochemistry, Bioengineering, Chemistry, Biology, Genetics or related field. * 0-2 years for PhD, 5+ years for MS/BS assay (product) development experience, preferably in medical devices of IVD diagnostics. * Extensive experience with real-time PCR primers and probes designs. * Experience with assay multiplexing and/or real time PCR or RT-PCR optimization. * Experience performing and optimizing nucleic acid extraction/purification. * Experience with primers and probes designs for SNP or mutation detection is a plus. * Experience with DNA methylation assay development (sample preparation and/or detection). * In-depth knowledge of cancer biology preferred. * Ability to ask questions and check for clarity and understanding. Solves complex problems. * Knowledge in handling clinical samples and ability to work in a BSL-2 environment. * Knowledge of biological and chemical safety. * Experience with product development/design control is a plus * Effective written and oral communication skills, presenting data within the technical team and department. * Proficiency with standard Microsoft computer programs. * Proficiency with statistical analysis tools such as Minitab or JMP. Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years. At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We’re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you’ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team. Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The EEO is the Law poster is available here.