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Scientist, New Product Introduction

  • Anywhere

Company :
Leica Biosystems

Location :
Sunnyvale, California

Expiry Date :
Mon, 26 Apr 2021 23:59:59 GMT

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Description :
Position Summary Senior Scientist II, New Product Introduction represents Manufacturing/Operations in cross-functional core teams for Cepheid s GX assay development. This person will be the technical partner to the R&D team throughout the life cycle of new GX assay products in ensuring manufacturability and testing strategy. Daily interaction and heavy engagement with R&D, Manufacturing Engineering, Manufacturing, and other functions within Cepheid is expected. Essential Job Responsibilities * Actively participate in the development of new products as a representative of manufacturing to ensure compatibility with current and future manufacturing processes and capabilities. * Partner with R&D team to assess manufacturability throughout the life cycle of new GX assay products. Conduct design for manufacturability (DFM) review meetings routinely. * As appropriate, serve as a technical liaison for other departments with regards to new product introduction activities, including, but not limited to, bill of materials, control material, reagent formulation, and product or consumables testing. * Lead, coordinate, or participate in operations-related activities required for the transfer of new products to routine production: * production scale-up * process development/optimization * technology transfer * process validation * test method validation * SAP extension and costing * Develop and maintain production documentation including procedures, worksheets, and bills of materials. * Uses in-depth of manufacturing and assay knowledge to troubleshoot assay design challenges encounteredduring the course of assay development, clinical validation or manufacturing validation.Assists junior team members in troubleshooting. * Maintain substantial and current knowledge of validation and process control requirements mandated by applicable regulatory bodies. * Leads smaller teams of product transfer associates or functional teams in the execution of complex projects. * Serves as a mentor to junior team members during project execution * Actively consults with other manufacturing teams as an assay subject matter expert to improve products, processes or services. Minimum Requirements * Bachelor s, Master s or Ph.D degree in Life Science, Biochemistry or Chemistry, or equivalent combination of education and experience to perform at this level * Understanding of Real Time PCR * Experience with molecular biology * Ability to work effectively with cross-functional core teams 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.