Product Transfer Scientist, Supervisor

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

 

The Product Transfer Scientist will supervise a team of supporting staff to facilitate the introduction of new products from development to production. In addition, this person will also represent Manufacturing/Operation in the 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 Product Transfer Scientist.

 

  • Supervise a team of Production Transfer Associates to provide efficient support to other Senior Product Transfer Scientists within New Production Introduction department.
  • Manage daily activities of PT Associates and cross train individuals ensure adequate and timely support of all new GX assay development projects.
  • 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
  • Develop and maintain production documentation including procedures, worksheets, and bills of materials.
  • Use professional skills to solve a wide range of difficult problems in imaginative and practical ways within the bounds of company policies and procedures.
  • Maintain substantial and current knowledge of validation and process control requirements mandated by applicable regulatory bodies.

 

 

Requirements

 

  • Ph.D./Master's degree in Life Science or equivalent combination of education and experience to perform at this level
  • Minimum of 5 years of R&D or relevant experience in medical devices, biotech, and/or pharmaceutical industries
  • Experience with QSR and ability to work within a regulated environment
  • Detail-oriented and multi-tasking
  • Ability to work effectively with cross-functional core teams

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How to Apply

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