BD (Becton, Dickinson and Company) Systems Verification and Validation Senior Scientist in Limerick, Ireland
Job Description Summary
At BD Biosciences, our purpose is to help all people live healthy lives. We are a world leader bringing innovative tools to research and clinical laboratories in basic research, drug discovery and development, biopharmaceutical production and disease management. We develop technology that enables faster diagnosis and better clinical outcomes.
To ensure that our cell analysis products deliver outstanding performance and exceed our customers’ expectations, BD Biosciences is seeking a passionate and capable Systems Verification and Validation Senior Scientist to contribute to a cross-disciplinary product development team, and to develop method improvements that drive greater efficiency and productivity of the Systems Verification and Validation team.
The Systems Verification and Validation (SVV) Senior Scientist leads 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 strategy, 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 Senior Scientist works closely with senior management, systems engineering, 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 is a highly trusted individual who exercises sound, independent judgment and applies systems thinking, problem solving, debugging, and troubleshooting to generate innovative ideas to improve BD products or processes.
The SVV Senior Scientist is a V&V team leader and cross-functional program representative. The Senior Scientist 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, scientific advancements in flow cytometry and the competitive landscape. He/She acts as an interface between customers and developers/testers by translating customer needs into product requirements and testing workflows. 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 SVV Senior Scientist leads projects or initiatives, including generation of project plans, development of test strategies that balance risk and business objectives, and directs large sized teams. The individual serves as a technical contributor on cross-functional teams, exercising influence across functions, and provides input to senior management on strategic and functional decisions.
The successful candidate will possess:
• Typically requires a minimum of a Bachelor’s Degree in Immunology, Cell Biology, or Clinical Laboratory Science with a minimum of 5 years relevant experience or a combination of equivalent education and experience.
• Typically requires B.S. or M.S. in Immunology, Cell Biology, Clinical Laboratory Science or related scientific discipline with a minimum of 5 years experience in clinical, research, pharma, medical device or other relevant industry
• Extensive 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
• Extensive 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
• Proven ability to execute complex experiments independently, perform in-depth statistical analysis, interpret experimental results, and make sound conclusions • Proven ability to apply creative problem solving skills to novel or complex applications • Proven ability to critically evaluate proposed study designs with strong knowledge of statistics, the calculation of sample sizes and/or estimation of statistical power
• Experience training bench-level personnel at multiple levels of education and/or expertise • Strong interpersonal skills with a proven ability to collaborate with others in multi-disciplinary team settings, influence decision making, and build group consensus
• Excellent written and oral communication skills
• Demonstrated success leading medium to large sized projects, with the ability to meet technical objectives and solve complex challenges under conditions of ambiguity and rapid change
• Experience managing timelines, budgets, and resources using project management tools such as PDWare, Microsoft Project, PERT charts, and Gantt charts
• Experience handling and processing infectious blood samples in a Biosafety Level 2 laboratory using universal precautions
• (Preferred) MS or PhD degree in Immunology, Cell Biology or in a related scientific discipline
• Strong knowledge of HIV, leukemia, lymphoma, hematology, and/or cancer biology
• Experience with genomics instrumentation, applications, and customer workflows
• Experience in human factors or usability engineering principles or studies
• 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
Primary Work Location
IRL Limerick - Castletroy
BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.