Scientist, New Product Introduction

Cepheid Sunnyvale , CA 94085

Posted 2 weeks ago

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.

Minimum Qualifications

  • Bachelors with 5 years experience or Master's degree in Life Science with 3 years' experience or Doctoral degree in Life Sciences with 0-2 years' experience.

  • Experience with Real Time PCR or Manufacturing Operations

  • Detail-oriented and multi-tasking

  • Ability to work effectively with cross-functional core teams

Preferred Qualifications

  • Experience within operations/manufacturing

  • 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
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Scientist, New Product Introduction

Cepheid