We are a fast growing Biotech company and the leading provider of diagnostic products in the field of transplant immunology and genetic disease predisposition testing. Our facility is located in Southern Fairfield County, Connecticut.
As an integral member of the manufacturing team, the Manufacturing Chemist will assists with manufacturing production to ensure continuous production of products consistent with established ISO standards.
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Formulates and maintains manufacturing objectives and coordinates with quality control to maximize product reliability, minimize costs and meet SBU and departmental productivity objectives.
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Performs production of all TLC products prior to sale or use, to ensure product quality and reliability. These may include, but is not limited to, Luminex based HLA typing kits and supporting reagents.
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Perform pre-shipment testing, in-process testing and inspection as required.
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Perform stability and validation testing
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Properly operate and appropriately maintain the equipment used in all job functions
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Document all manufacturing protocols and procedures to ensure organized and consistent laboratory testing activities
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Follow published Manufacturing Procedures and in accordance with ISO13485 and GMP
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Maintains Inventory controls and provides data input into Great Plains GRP.
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