Scientist/Senior Scientist, Product Transfer|
Combines molecular biology knowledge with a technical understanding of Cepheid systems to play a key role within the Product Transfer group. Works together with Manufacturing, Quality, Regulatory and Materials Planning/Logistics departments to ensure the transfer of new products and processes and the continued production of cost-effective quality products. Identifies and implements new, streamlined, or improved processes into production.
- Leads projects to ensure the continued production of cost-effective quality products and streamline processes.
- Successfully implements post-launch product improvements in production, including improvement and validation of test methods, training of personnel, and implementation of all supporting documentation (BOMs, SOPs, worksheets, Design History, etc.).
- Drives, designs, and performs experiments in support of validation/qualification activities and process improvement projects.
- Performs testing of biological/chemical assays, as needed, to support ongoing project activities and goals. Analyzes data and participates in root cause analysis and design of solutions. Writes reports compliant with FDA regulations.
Education or Experience:
- Bachelors+5 years of experience OR
- Masters degree in relevant field +3 years of experience OR
- Ph.D in relevant field +0-2 years of experience.
Knowledge and skills:
- Proficiency in molecular biology techniques including real-time PCR.
- Proficiency in Microsoft Excel including management and manipulation of large datasets.
- Excellent organization and communication skills.
- Ability to successfully interact with multiple departments. Demonstrate strong ethics and teamwork.
- Ability to handle multiple projects simultaneously, with tight timelines, and progress independently in a timely manner.
- Ability to work in an office, laboratory, and production environment.
- Bachelor's+8 years of experience OR Masters degree in relevant field +6 years of experience OR Ph.D. in relevant field +3 years of experience.
- Hands-on experience in Operations functions, including a solid understanding of batch records, bills of materials, logistics and inventory parameters, costing parameters, document management systems, ERP systems, etc.
- Practical understanding and use of statistical techniques for data analysis.
- Experience with molecular diagnostic assays.
The statements in this description represent typical elements, criteria and general work performed. They are not intended to be an exhaustive list of all responsibilities, duties, and skills for this job.
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