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We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development.
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Partners with CMC, Clinical Development, Clinical Operations and Pharmacology to ensure GMP, GLP and GCP compliance for all clinical development programs by providing guidance. Oversee GMP, GLP and GCP compliance audits (US and international), including contract manufacturing sites, analytical testing sites, clinical storage and distribution sites, clinical investigator sites, contract test laboratories, and CROs to determine compliance status and to identify compliance risks.
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DE performing full stack development in an Information Technology (IT) product development organization, and Amazon Web Services (AWS) environment, using TypeScript, Node.js, Java, API development, Spring Boot, Apache Tomcat, and RDBMS; and analyzing, designing, developing, and testing scalable Cloud based software applications.
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About Insourcing Solutions Charles River Insourcing Solutions℠ can streamline research by delivering operational and cost efficiencies through the strategic insourcing of GMP, GLP and non-GLP research services from discovery through safety assessment.
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Pearson VUE ( is the global leader in computer-based testing for information technology, academic, government and professional testing programs around the world. Pearson VUE provides a full suite of services from test development to data management and delivers exams through the world’s most comprehensive and secure network of test centers in more than 180 countries, where we validate the skills and knowledge of millions of individuals every year.
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Description The Process Research(PR) group within Synthetic Molecule Process Development (SMPD) is a global team responsible for interfacing with Takeda’s Discovery functions (e.g. medicinal chemistry, DMPK, Drug Safety) with the goal of route identification and phase appropriate route development to deliver GLP Tox and Ph 1 GMP Drug Substance (DS.
$205,100 - $322,300 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Todos os dias, estamos pensando grande e trabalhando de forma inteligente para resolver alguns dos desafios mais difíceis que impactam o mundo, seja facilitando a água potável para as comunidades, criando cidades resilientes ao clima ou projetando espaços de vida mais confortáveis, nunca nos contentamos com o "bom o suficiente" quando há uma oportunidade de tornar a vida melhor.
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Experience in flow cytometry, microbiology, PCR and ELISA testing is a plus. Demonstrate basic knowledge of the GXP cellular therapy product manufacturing, and program development and evaluation, as well as needs assessment and marketing of the programWorking knowledge of flow cytometry, molecular biology, and genetic engineering is a plus.
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Working in close collaboration with other Analytical Development team members, the Scientist I/II will develop and qualify advanced biophysical and analytical methods for AAV vectors to measure key quality attributes for AAV therapeutic materials, to support process development, product characterizations, and QC release testing.
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Key Responsibilities of a Process Development Engineer: Design and development of equipment, processes, and control systems, used for production and assembly of cell encapsulation devices.
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DNA characterization and quality control testing using techniques such as gel electrophoresis, RNaseA testing, nanodrop, PCR, and preparation of samples for sequencing analysis (Sanger and NGS.
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The TeamAs part of IM’s Quantitative Research and Development group, the “Quantitative Product Management” team focuses on initiatives that improve or create new capabilities and tools for portfolio management and Asset Liability Management stakeholders.
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This involves the development of a control system architecture, selecting the components to be used, detailing schematic diagrams and system documentation, programming controllers (PLC, DCS, RTU), programming the process visualization (HMI/SCADA), developing databases for archiving/displaying historical system data and implementing/commissioning the control system at the client’s facility.
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Work Experience: 10+ years in Model Development and/or Validation of, Compliance, transaction monitoring, Below the Line testing, and Risk Management function at an investment bank or hedge fund.
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Systems include but are not limited to EPIC, Optility, PET Manager, Syngo, and ·Alerts Unit Technical/Operations Manager regarding equipment problems, problems encountered during testing, etc. ·Follows the instructions of the Authorized User (AU) physician and authorized nuclear pharmacist for the preparation of radiopharmaceuticals and quality control testing.
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glp testing development jobs Company: Ascend Advanced Therapies in Woburn, MA
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