Senior Scientist- Assay Development

Job Description

About UsDanaher Profile:Danaher is a global science and technology innovator committed to helping our customers solve complex challenges and improve quality of life around the world. Our family of world class brands have unparalleled leadership positions in some of the most demanding and attractive industries. Our team of over 59,000 associates around the globe is united by a powerful business system which serves as our ultimate competitive advantage. In 2014, we generated $19.9 billion in revenue, earned a spot on the Fortune 150 list and over the past 20 years, our stock has outperformed the S&P 500 Index by nearly 2,800 percent Danaher is where great people do extraordinary things! Our quiet quest to expand and build high-performing businesses across a variety of industries requires top-notch students that seek a challenging career path.Our consistent success is the direct result of our people and the Danaher Business System (DBS). DBS has evolved from a collection of manufacturing improvement tools into a philosophy, set of values and series of management processes that collectively define who we are and how we do what we do. Today, our DBS tools are designed to help us excel in areas of GROWTH, LEADERSHIP and LEAN.Danaher associates are pursuing a focused strategy aimed at building businesses that matter within four (4) strategic platforms: Environmental, Dental, Life Sciences & Diagnostics, and Applied Sciences.Beckman Coulter Life Sciences mission is to empower those seeking answers to life s most important scientific and healthcare questions. With a legacy spanning 80+ years, we have long been a trusted partner to our customers, who are working to transform science and healthcare with the next groundbreaking discovery. As part of our team of more than 2,900 associates across 130 countries, you ll help drive our vision of accelerating answers and our commitment to excellence.Beckman Coulter Life Sciences is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.Job title: Senior Scientist- Assay DevelopmentBased in Bangalore, India (On-site)Job Description Summary: The Senior Scientist will ensure the overall success of R&D deliverables in the area of new clinical flow cytometry reagent. The responsibilities include working with project R&D scientists across all stages of IVD assay development through concept, development, validation, and launch. Candidates should have strong problem solving skills, Candidates must have strong technical and scientific training in engineering or life sciences during their academic training followed by similar relevant experience in a research setting.Primary Responsibilities: - Responsibility for coordinating successful completion of R&D development deliverables on time with high quality. Ensuring assay development efforts are consistent and comply with IVD directives and Beckman design controls- Technical areas includes , broadly-
• Design of reagents, experimental approach, wet-lab, data analysis, review, and interpretation, technical troubleshooting, investigation and presenting the data.
• Study plans/ protocols/ reports for Assay analytical/ diagnostic performances as required for IVD/510(k) clearance
• Risk management including FMEA, Human factors
• System integration assessments include impact on reagent performance from instrument/software design changes or feature changes.
• Demonstrate expertise in the experimental design, execution, and statistical data analysis (including various statistical analysis tools, like JMP or Minitab). - Train other new R&D associates and develop them in IVD development- Work in a fast-paced, team-oriented, multidisciplinary environment with fluctuating priorities and deadlines.Gains a broad understanding of all functions involved, address dependencies & needs of all functional team required from R&D and can leverage the team to close gaps Such as instructions for use/inserts/system guides for clinical or field applicationsStays abreast of key issues and trends utilizing internal and external contacts and industry data to identify potential opportunities or threats to the company.- Has an understanding of the project schedule to the extent that impacts are understood immediately and counter-measured as needed, and has an extensive understanding of the product development process and design controls. -Education and/or Experience:Masters or Ph.D.in Immunology, Biology or related life sciences field with a minimum of 8 years Industrial/ clinical experienceDesired Skills but not mandatory- Experience in Reagent/ Assay/ Medical devide development throught the whole stage gate system including 510(k) submission and IVD-R submissions
When you join us, you ll also be joining Danaher s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.Danaher is committed to a diverse and inclusive culture where everyone feels they belong, and all voices are heard. We believe in our associates and the unique perspectives they bring to every challenge, which is why we ll empower you to push the boundaries of what s possible.If you ve ever wondered what s within you, there s no better time to find out.When you join us, you ll also be joining Danaher s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.At Danaher, 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.If you ve ever wondered what s within you, there s no better time to find out.,

Keyskills :
researchvalidationdocumentationapihplcstatistical data analysisstatistical analysis toolsdata analysislife sciencesflow cytometryassay development