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Danaher Corporation Scientist, Product Transfer in Sunnyvale, California

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 Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible.

Are you a scientist/bioengineer with expertise in molecular biology, real-time PCR, and/or protein science who has the ability to lead critical reagent change projects for molecular diagnostic products? This is an exciting opportunity to work with cross functional teams such as manufacturing, engineering, R&D, quality, supply chain, and regulatory to ensure manufacturing processes and designs are robust and sustainable!

Position Summary

The successful candidate will play a key role in Manufacturing Science/Operations by combining a deep expertise in molecular biology/real-time PCR and a technical understanding of Cepheid assays and systems to implement key changes to raw materials, reagents, processes, and/or product structure. Partners with multiple departments to design robust processes that support molecular diagnostics assay manufacturing. Drives product improvements to ensure product quality, sustain manufacturability, and improve margins of Cepheid assays.

Responsibilities

  • Effectively collaborates and handles the progress of cross-functional projects with an efficient use of resources and timelines. Acts as liaison and aligns with functions such as manufacturing, engineering, R&D, quality, supply chain, and regulatory to ensure processes and designs are robust and sustainable.

  • Drives, designs, and performs experiments in support of validation/qualification activities and process improvement projects.

  • Conducts qualification, verification, and validation testing and documentation.

Minimum requirements:

Education or Experience:

  • Leads the development and implementation of strategic improvements required for ensuring manufacturability, scale-up, cost effectiveness, and improving product quality of reagents and assays. Responsible for manufacturing and supporting documentation (BOMs, SOPs, worksheets, Design History, etc.).

  • Experience with real-time PCR and molecular diagnostic assays.

  • Hands-on experience in Operations functions, including an understanding of batch records, bills of materials, logistics and inventory parameters, costing parameters, document management systems, ERP systems, etc

  • Bachelor’s +5 years of experience OR Master’s degree in relevant field +3 years of experience OR Ph.D. in relevant field + 0-2 years of experience.

Knowledge and skills:

  • In-depth knowledge of and experience with molecular biology techniques and assay/reagent development.

  • Excellent organization and communication skills.

  • Working experience with ISO 13485 and ISO 14971.

Physical requirements/abilities:

  • Ability to work in an office, laboratory, and production environment

Preferred requirements:

  • 2-4 years in-depth technical project leadership in a regulated industry.

  • Experience in authoring and editing documentation for verification and validation activities such as protocols and reports..

  • Experience in product/reagent launches.

  • Experience with enzyme/protein production, scale-up, and/or lyophilization.

Cepheid, 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 danaherbenefitsinfo.com.

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 (https://www.danaher.com/how-we-work/danaher-business-system) 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 here (https://www.dol.gov/agencies/ofccp/posters) .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 applyassistance@danaher.com to request accommodation. If you’ve ever wondered what’s within you, there’s no better time to find out.

Operating Company: Cepheid

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