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Scientist, Product Transfer

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 Danaher Business System which makes everything possible.

The Scientist, Product Transfer role represents Manufacturing/Operations in cross-functional new product development (NPD) instruments/software/assay core teams. This person will be the technical partner to NPD teams throughout the life cycle of new products in ensuring compatibility with Cepheid manufacturing. Daily interaction and heavy engagement with R&D, Manufacturing, Quality, Supply Chain, and other functions within Cepheid is expected.

This position is part of the Manufacturing Science team and will be located in Sunnyvale, CA.

In this role, you will have the opportunity to:
Actively participate in NPD core teams as a manufacturing representative to ensure compatibility with current and future manufacturing processes and capabilities.
Partner with R&D/Engineering/Software teams to assess and design for compatibility with Cepheid manufacturing throughout the life cycle of new products.
Lead, coordinate, or participate in operations-related activities required for the transfer/sustainment of NPD assays, and/or platforms into manufacturing. These activities include: Production scale-up
Process development
Test method validation
SAP extension and costing
Process validation
IQ/OQ/PQ
Development and maintenance of production documentation including procedures, worksheets, and bills of materials.
Process improvement

Use in-depth knowledge of manufacturing, assay, software, and/or instrumentation to troubleshoot assay design challenges encountered during assay development, clinical validation, manufacturing validation, and/or post-launch.
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.

The essential requirements of the job include:

Bachelor's degree in related field with 5+ years of related work experience, OR Master's degree in related field with 3+ years of related work experience, OR Doctoral degree in related field with 0-2 years of related work experience.
Strong analytical and problem-solving skills. Must be detailed oriented.
Experience with qPCR.
Proficiency in Excel, Microsoft Word, and PowerPoint.
Excellent documentation, writing, communication, and organizational skills.

It would be a plus if you also possess previous experience in:
Hands-on experience in Operations functions, including a solid understanding of batch records, bills of materials, logistics and inventory parameters, costing parameters, document management systems, ERP systems, etc.
Experience with Molecular Diagnostic Assays
Experience working within an ISO 13485 / ISO 9001 regulated environment

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 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 .

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.

Keywords: Cepheid, Sunnyvale , Scientist, Product Transfer, Professions , Sunnyvale, California

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