The Reagent Production and Testing Manager will oversee the production activities of the reagent manufacturing group that includes bulk reagent formulation, lyophilization, product inspection and inprocess product testing, to ensure products are made in accordance to SOP and meet Cepheid specifications.
Work closely with planning to adjust staff scheduling to meet product availability and in process testing requirements. Participate in the transfer and development of new reagent formulation and manufacturing process. Assist in the investigation and closure of production issues. Collect and analyze department performance data to identify areas for efficiency, quality, output, and manufacturing costs improvement projects.
- Manage the day to day activities to support reagent manufacturing and WIP testing.
- Analyze department performance and identify areas for improvement and scale up activities that will increase efficiency, product yield and reduce production costs.
- Work with development and product transfer for introduction of new products and investigation of product non-conformance.
- Develop a manufacturing process for controls and test reference materials.
- Ensure production is in compliance to cGMP/QSR/ISO standards.
- Prepare documentation, reports and standard operating procedures as required.
- BS degree in Life Science or Chemical Engineering.
- Minimum of 3 years managing a Reagent Production group in an FDA and ISO compliant environment.
- Experience in development and transfer of chemical formulation and scale up of reagent manufacturing processes.
- Lean/Six Sigma project experience.
- Excellent Microsoft Excel skills in data analysis, chart and report generation.
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