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Position:
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 f

Employer:
Cepheid

Description:

SCIENTIST, NEW PRODUCT INTRODUCTION

 

This role represents 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 encouraged.

Essential 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 which will include:
  • production scale-up
  • process development/optimization
  • technology transfer
  • process validation
  • test method validation
  • SAP extension and costing
  • You will develop and maintain production documentation including procedures, worksheets, and bills of materials.
  • This role will use your technical knowledge to solve 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.

 



Qualifications/Experience:
  • Bachelor’s degree in field with 5+ years of related work experience OR
  • Master’s degree in field with 3+ years of related work experience OR
  • Doctoral degree in field with 0-2 years of related work experience.

 

Knowledge and skills:

  • Experience with Real Time PCR
  • Detail-oriented and multi-tasking
  • Ability to work effectively with multi-functional core teams

Preferred Qualifications

  • Bachelor's or Master's degree in Chemistry, Biochemistry, or Life Science +2 or more years of proven experience
  • Experience with Design for Manufacturing

 

 



Location: Sunnyvale, CA

Contact: Cbishop01@dhdiagnostics.com

Post Date: 8/17/2020 6:37:35 PM
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