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Oversee the operational activities and SDLC management of critical systems such as LIMS, ELN, LES, QMS, and instrument workstation applications, encompassing end-user support, compliance sustainability, monitoring, patch/release management, backup/recovery, administration, troubleshooting, change control, deviation/CAPA management, and issue resolution.
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Maintain excellent documentation of all work including LIMS, test methods, and protocols. Perform quantitative LC-MS/MS (Liquid Chromatography Mass Spectrometry) analysis of small molecules from various bio-matrices in vivo and in vitro to support PK/PD, ADME, efficacy and exploratory toxicology studies.
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They are building a laboratory information management system (LIS or LIMS) for our growing specialty diagnostic and clinical research divisions and for our customers. Through our clinical divisions (Specialty Anatomic Pathology, Molecular Diagnostics, Flow Cytometry, Cytogenetics and Genomics) and the utilization of automation and a host of advanced molecular technologies, we perform and interpret more than 500,000 specialized tests annually, with specimens emanating from thirty-one states and forty-six countries.
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Experience with Software as a Service (SaaS) enterprise systems such as electronic quality managements systems (eQMS), Enterprise Resource planning (ERP), Laboratory Information Management Systems (LIMS) and Supervisory Control and Data Acquisition (SCADA), Building Management Systems (BMS) and analysis tools.
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Oversee CROs to produce recombinant proteins and antibodies for in vitro screening and scale-up for in vivo studies, manage in-house inventory, help build LIMS and lab as company grows. Experience within silico tools for developability screening, antibody engineering, LIMS.
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Partners with knowledge management leads within Boar's Head to ensure and maintain consistency on Standard Operating Procedures and formal Work Instructions that outline use of several enterprise-wide applications (Ex. Oracle ERP, Oracle Business Intelligence, Tableau, QMS, LIMS, MES, etc.
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Must have experience within FDA / GxP / LIMS (LabWare) Pharma regulated environments. Experience with LIMS Basic and ELN are preferred. along with GxP and manufacturing applications such as Werum/Koerber PAS-X, Blue Mountain RAM, TraceLink, Dell Boomi, and Optel Vision Systems in a regulated, validated environment.
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Interact seamlessly with multi-disciplinary teams such as automation, laboratory infrastructure (e.g. LIMS), clinical, bioinformatics / data analysis, regulatory and marketing groups. Strong background in assay development using molecular genomic technologies (both RNA and DNA), including experience in next-generation sequencing, microarray, or other high-throughput platforms.
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This hybrid onsite and remote role will provide technical support for various LIMS / LabWare along with GxP and manufacturing applications such as Werum/Koerber PAS-X, Blue Mountain RAM, TraceLink, Dell Boomi, and Optel Vision Systems in a regulated, validated environment.
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This individual will support the Quality business community executing requirements and coordinating with the technical community, IT project teams and business clients for Quality technical solutions including QMS, CDS, QC RDS, LIMS, NuGenesis ALM, etc.
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Knowledge of integrating LIMS with Empower CDS. Strong understanding of LIMS solutions (LabVantage preferred) Experience with IT setup, troubleshooting, back-up, upgrades, & decommissioning lab equipment/software such as HPLC, GC, AA, UV/FTIR/Raman, titrators, endotoxins, total particulates, balances, pH meters, etc.
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Experience with Laboratory Information Management Systems (LIMS), Manufacturing Management Systems(MES), scheduling software, Customer Relationship Management (CRM) software, Green Button Go (GBG.
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In addition to leading bleeding-edge bioinformatics and LIMS, you will help us establish a strong culture of mutual respect, integrity, and collaboration while working alongside some of Silicon Valley’s best scientists and engineers.
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Manage the development of Elegen's in-house Laboratory Information Management System (LIMS). B.S. or M.S. in computer science, bioinformatics, computational biology, genomics, or a related field with 7 years of industry experience or Ph. D. with 3 years of experience.
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Functional operations and technical proficiency Responsible for on-time and in full execution of laboratory responsibilities such as sample management, performing assigned analytical methods, recording data and observations in the electronic lab notebook and LIMS, preparing data reports, and working with Associates to analyze data for insights.
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