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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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