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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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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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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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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.
$50 - $58.62 an hourExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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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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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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This is a senior-level position that requires a deep understanding of the financial markets, exceptional networking skills, and a strong background in commercial real estate development. Coordinate and manage regional & international travel arrangements for investor presentations with WS Development senior leadership.
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Desired Qualifications: B.S or M.S. Degree in Civil Engineering Licensed Professional Engineer (PE), or (EIT) 3+ years of demonstrated engineering design of Land Development Projects Utility Design Site Grading Storm Water Management Systems Zoning Research Permitting Research Proficiency with AutoCAD, Civil 3D software Salary and Benefits: Comprehensive Salary Package.
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As an viral vector process SME, support other functions including strategy for testing of raw materials, pre-clinical development, reference standards and assay validations, etc. A minimum of 10+ yrs hands on experience in Process Development of cell therapy and/or gene therapy products.
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Understands, conducts, and documents appropriately Dialysis/Apheresis machine safety tests/alarm tests, equipment calibration, dialysate testing, machine safety tests, functional testing, and internal and external disinfection on all water & dialysis machines, and complies with the documentation/notification standards per FMS policies.
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Minimum of 5+ years of progressive Quality experience working in regulated environment preferably in the field of biotechnology, biopharma, and/or cell/gene therapy (deep experience with GLP or GCP preferred.
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Deep expertise and industry experience in cell therapy process development principals including DOE and experience with current technologies in PSC process development and manufacturing, particularly scalable stem cell culture systems such as bioreactors.
$290,000 - $340,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Job Description The group seeks a Student Technical Assistant to work with our engineering staff on advanced concept demonstrations in the areas of data analysis, algorithm development, software development, digital signal processing, hardware design, and flight test support.
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Principal Scientist, Protein Production and Process Development. and with proteins expressed in mammalian cells with oversight of both upstream and downstream process development. The incumbent will interface with internal preclinical Immunology, Protein Modality, and DECODE platform teams, as well as the internal CMC Leader, to provide protein reagents and protein leads, including data packages supporting Development Candidate nomination.
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glp testing development jobs in Lexington, MA
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