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New Product Introduction Scientist

Company: Cepheid
Location: Sunnyvale
Posted on: November 22, 2021

Job Description:

At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world s most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development.Cepheid is proud to work alongside a community of six fellow Danaher Diagnostics companies. Together, we re working at the pace of change on diagnostic tools that address the world s biggest health challenges, driven by knowing that behind every test there is a patient waiting.Learn about the which makes everything possible.Essential Job Responsibilities:

  • Actively participate in the development of new products as a representative of manufacturing operations 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, manufacturing processes and product 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 encountered during the course of assay development, clinical validation or manufacturing validation.Assists 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.
    • Actively consults with other manufacturing teams as an assay subject matter expert to improve products, processes or services.Minimum Requirements:
      • Master s degree or Ph.D. in Life Sciences, Bioengineering or Engineering with 2 years of relevant experience or Bachelor s degree with 10 years of relevant experience.
      • Ability to manage multiple projects simultaneously with short deadlines
      • Ability to communicate technical issues both verbally and in written form
      • Effective organization and planning skills
      • Excellent communication skills and the ability to develop working relationships with multiple departments
      • Proficiency in Molecular Biology techniques.Preferred Requirements:
        • Experience working in a manufacturing environment and/or within manufacturing operations under cGMP, ISO and FDA regulations.
        • Deep knowledge of qPCRCepheid, a Danaher company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at .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 tools and the stability of a tested organization.Danaher Corporation and all Danaher Companies require all US and Puerto Rico employees to be vaccinated against COVID 19 as a condition of employment, subject to reasonable accommodation as required by law.Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. 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.The EEO posters are available .We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at to request accommodation.If you ve ever wondered what s within you, there s no better time to find out. Associated topics: biochemistry, biomaterials, biomechanics, biophysics, bioprocessing, genetic, medical, molecular, neuro, pathogenesis

Keywords: Cepheid, Sunnyvale , New Product Introduction Scientist, Other , Sunnyvale, California

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