Product Transfer Associate

Organization
Cepheid - US
Job Location
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Sunnyvale, CA 94089
Job Description

The Product Transfer Associate will support Product Transfer Scientists in New Product Introduction (NPI) team to ensure the successful transfer, validation, and commercialization of Cepheid’s new IVD products. Duties include developing bills of materials (BOM), development or revision of manufacturing worksheets and procedures, new materials qualification, test method validation, handling logistics for development builds, and writing validation reports.

 

  • Perform routine product transfer activities to support New Production Introduction function within Operations.
  • Conduct testing of biological/chemical assays and instrumentation in support of test method validation or new materials qualification.
  • Scope of testing will include preparation of reagents/chemicals, performing testing using instrumentation and application software, follow both established procedures and conducting non-standard testing under the guidance of the Sr. Product Transfer Scientists.
  • Analyze data using established procedures and summarize in a report format.
  • Support process improvement and troubleshooting efforts as needed within Operations.
  • Support the development of manufacturing worksheets and procedures in new product introduction.
  • Bachelor’s degree in a Life Science discipline; or equivalent combination of education and experience to perform at this level.
  • A minimum of 4 years direct related experience or equivalent combination of education and experience to perform at this level.
  • Basic knowledge of GLP practices involving biological/chemical reagent handling and formulation.
  • Basic knowledge of molecular biology techniques, especially work with nucleic acids and biochemicals.
  • Basic knowledge of chemicals used in reagent assay formulations and safe handling of hazardous chemicals.
  • Knowledge of laboratory equipment (e.g. pipettors, spectrophotometers, titrators).
  • Proficient use of MS suite of tools such as Excel, Word.
  • Excellent verbal and written communication skills.
  • Attention to detail and good record-keeping skills.
  • Organized, detailed oriented and a self-driver and capable of working independently under minimal supervision.
  • Demonstrate strong ethics and teamwork.
  • Basic understanding of mathematics and formulas used for calculations.
  • Ability to follow oral and written procedures.
  • Ability to follow SOPs, work instructions and related documentation.
  • Capable of working independently under minimal supervision.

 

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