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Scientist III, Systems Verification

Katalyst Healthcares & Life Sciences
San Jose, CA
Closing date
Dec 1, 2021

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Job DescriptionOverview
  • The Scientist III, Systems Verification participates in the definition, design, and execution of SVV activities throughout all phases of the product development process for BD Biosciences cellular analysis systems. This includes the design of test methods and test strategies, development and execution of formal protocols, analysis and interpretation of results, and communication of results and their impact through written reports, design reviews, and interactive discussions. The Scientist works closely with systems engineers, marketing, and the product development team to support the successful application of new technologies and ensure that the system design meets technical, customer, and regulatory agency requirements. He/She regularly exercises sound, independent judgment and applies systems thinking, problem solving, debugging, and troubleshooting to generate innovative ideas to improve BD products or processes.
  • The Scientist III role is a hands-on testing and problem-solving role. The Scientist III conducts experiments using flow cytometry and applies strong knowledge in scientific principles, immunology, sample manipulation, and/or immunoassays to influence best practice laboratory procedures and study designs. The individual maintains up-to-date knowledge of customer workflows and scientific advancements in flow cytometry and will be called upon to represent the voice of the customer to product developers and assist with translating the customer needs to product requirements. He/she understands and communicates the broader impact of design features, test methods, and results to the user, customer, regulator, and to the marketability of the product. The Scientist III leads projects or initiatives, including generation of project plans, development of test strategies that balance risk and business objectives, and directs small to medium sized teams. The individual exercises influence across functions, and contributes to cross-functional problem solving.

  • Minimum of a Bachelor's Degree in Immunology, Cell Biology, or Clinical Laboratory Science with a minimum of 2 years relevant experience or a combination of equivalent education and experience.
  • Hands on experience operating and troubleshooting flow cytometry analyzers and/or sorters, with knowledge of flow cytometry instrument platforms, applications and software, assay panel development and customer workflows.
  • Experience designing and optimizing multi-parameter flow cytometry applications which may include: immunophenotyping, apoptosis, cell proliferation, cell activation, receptor expression, and/or intracellular calcium flux.
  • Experience researching and applying scientific principles to create new or optimize existing laboratory procedures, with an focus hematology, immunology, and/or molecular genetics.
  • Experience performing statistical analysis and interpreting experimental results.
  • Ability to apply creative problem solving skills to novel or complex applications.
  • Ability to critically evaluate proposed study designs with basic knowledge of statistics, the calculation of sample sizes and/or estimation of statistical power.
  • Ability to train bench-level personnel at multiple levels of education and/or expertise.
  • Strong interpersonal skills with the ability to collaborate with others in a multi-disciplinary team.
  • Excellent written and oral communication skills.
  • Demonstrated success leading projects, with the ability to meet technical objectives and solve challenges under conditions of ambiguity and rapid change.
  • Experience handling and processing infectious blood samples in a Biosafety Level 2 laboratory using universal precautions.
  • MS degree in Immunology, Cell Biology or in a related scientific discipline.
  • Knowledge or experience with genomics instrumentation, applications, and customer workflows.
  • Working knowledge of cellular and molecular immunology, in normal and pathological conditions.
  • Experience working within a regulated medical device industry with knowledge or experience in FDA submissions.
  • Familiar with accreditation and guiding agencies for the clinical laboratory including CAP, CLIA, and CLSI, including experience in audits conducted by accrediting bodies.
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