Sr. Scientist in Sunnyvale, California at Cepheid

Date Posted: 7/11/2018

Job Snapshot

Job Description

Job ID: CEP001580

About Us

At Cepheid, we are passionate about improving healthcare through faster, more accurate diagnostic tests. With our GeneXpert® System, we’ve taken the most sophisticated molecular technology and packaged it into an automated, easy-to-use format that has quickly become the platform of choice worldwide. From the largest laboratories to small physician offices, our game-changing solution delivers critical answers when clinicians and patients need them most. Through strong molecular biology capabilities and ongoing product innovation, we are focused on developing tests for healthcare-associated infections, sexual health, critical infectious disease, virology, and oncology applications. Come join our vision for a better way and help make life better for us all! For more details, visit us at www.cepheid.com or follow us on Twitter (@CepheidNews).


Description

Job Summary


The Sr. Product Transfer Scientist 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. Daily interaction and heavy engagement with R&D, Manufacturing Engineering, Manufacturing, and other functions within Cepheid is expected of this Sr. Product Transfer Scientist.



Responsibilities



  • Actively participate in the development of new products as a representative of Technical 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, reference 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.

  • Use technical knowledge to troubleshoot assay design challenges encountered during the course of assay development, clinical validation or manufacturing validation.

  • Maintain substantial and current knowledge of validation and process control requirements mandated by applicable regulatory bodies.

Job Requirements



Qualifications

Minimum Qualifications



  • Master’s degree in Life Science, Ph.D or equivalent combination of education and experience to perform at this level

  • Experience with Real Time PCR

  • Detail-oriented and multi-tasking

  • Ability to work effectively with cross-functional core teams


Preferred Qualifications



  • Experience within

  • Experience with Design for Manufacturing

  • Experience in molecular diagnostics development.

  • Experience with Quality System Regulations.

  • Familiarity with medical device regulations in US and CE markets

  • Familiarity with infectious disease or cancer biology.


Physical Demands



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


Danaher Corporation Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 67,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $18.3B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,200% over 20 years.

At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We’re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you’ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.