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We are seeking at least 3 years in clinical assay development, validation and implementation, with a track record of high impact in drug development. We are seeking to hire a Precision Medicine Strategy Lead (PMSL) role to oversee the development and execution of biomarker strategies for Genetic Medicines involving novel therapeutic modalities across multiple disease areas including rare genetic disorders and/or neurodegenerative conditions.
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The company has developed a proprietary, cost-effective molecular diagnostic assay to detect and identify bacterial and fungal pathogens in whole blood, without the need for culture. Prior experience performing experimentation (bench work) in a biopharmaceutical or molecular diagnostic process development laboratory is preferred (including PCR, nucleic acid extraction, microarray.
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Global Marketing Manager, you will be responsible for upstream and downstream activitiesYour role:·
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Comprehensive knowledge of the clinical research and assay development. Knowledge of project management discipline as it is applied to assay development. Act as technical SME of the clinical immunological and diagnostic assay portfolio.
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Ensuring that assays performed at external laboratories supporting Pfizer clinical studies are qualified or validated (as appropriate) and assay-associated tasks performed at external laboratories are done in a compliant fashion, in accordance with prevailing SOPs, and GCLP/GLP/GMP regulations, as appropriate.
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A fundamental understanding of the principles of assay development and experience with optimizing existing methods for bioprocess characterization is highly preferred. Cross-train on and provide support for upstream and downstream process development operations.
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