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.
- 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.
· 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
Organization: Siemens Healthineers
Company: Siemens Healthcare Diagnostics Inc.
Experience Level: Mid-level Professional
Job Type: Full-time
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