IT Manager - Computer BioAnalytical Systems

November 23

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ProKidney Corp.

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Description

• Join us in developing pioneering therapies that aim to transform the treatment of CKD and change patients’ lives. • Responsible for the implementation and support of technology and informatics systems for Laboratory Operations and other clinical applications. • Requires a broad understanding of regulatory frameworks and the ability to translate business problems into technology solutions.

Requirements

• Bachelor’s degree in computer science or related discipline, or equivalent experience. • 3+ years of implementing and supporting Clinical Trials and R&D applications in biotechnology or life sciences companies. • Strong Working Experience in developing and driving Computer System Validation program initiatives including GxP systems and ensuring CFR part 11 compliance. • Experience leveraging R&D Informatics applications to drive business workflows and processes in quality-manufacturing production environments. • Experience in establishing Posit, R and/or Python technology environments and establishing the use of AWS high-performance computing environments. • Experience implementing AWS High Performance Computing solutions. • Previous experience in the biotechnology / pharmaceutical industries and GMP Quality Systems. Experience with key business solutions such as QMS, ERP, LIMS, ELN, SAS • CRO experience highly preferred.