Senior Scientist – Tech Operations

Job Description


As a senior scientist within the Technical Operations group, you will provide technical support for the manufacturing, process development/improvement, and troubleshooting of immunochemistry reagent tests, and urinalysis/diabetes reagent intermediates, controls, and finished products.

Responsibilities

  • Provide technical support for immunoassay reagent cartridge manufacturing, process development, and production scale-up activities
  • Provide technical assistance to Quality Control with respect to incoming raw material and intermediate/finished product testing
  • Provide technical support for process improvement and implementation of changes on current production processes
  • Support the technology transfer of immunoassay wet chemistry and bead manufacturing processes to new facility
  • Support new product introduction (new immunoassays), including part of DMR and or QMS documentation
  • Design and conduct validation and verification activities to ensure project completion within expected parameters and time frame.
  • Design and conduct experiments to identify and resolve process issues related to undesirable reagent or manufacturing performance
  • Apply principals of lean manufacturing and support continuous improvement activities to meet quality, cost and supply requirements.
  • Participate/Lead Root Cause Analysis sessions
  • Provide technical assistance for urinalysis and diabetes reagent intermediates and finished products as part of the Technical Operation team.


Profile 

·        Bachelor’s Degree or higher in Biochemistry or Chemistry, or related studies

·        Minimum 3 to 5 years experiences in immunochemistry, preferably in a manufacturing environment 

·        Experience with working in projects in IVD setting, preferably POC 

·        Experience with wet chemical lab processes (GMP/GLP)

·        Experience with Product Creation and Quality Processes (ISO13485) 

·        Characteristics: Team-player, highly self-motivated, hands-on, well-organized, detail-oriented, pragmatic

·        Good analytical, communication, and report-writing skills 

·        Ability to work well on multi-disciplinary teams and independently

·        Effective and influential in his/her interactions in team-based assignments


   

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Organization: Siemens Healthineers

Company: Siemens Healthcare Diagnostics Inc.

Experience Level: Mid-level Professional

Job Type: Full-time



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