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The Senior Analyst / Scientist will also support the gene therapy program pipeline including but not limited to technical transfer, method qualification, validation, verification, routine GMP testing of AAV vector analytical methods (HPLC, AUC, UV, CE-SDS, compendia methods and other methods as needed) for lot release and stability.
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Transfer bioanalytical assays to CROs, oversee assay validation and sample testing. Design, develop and/or optimize sensitive quantitative GLP-like ligand-binding assays (LBAs) according to bioanalytical guidance to industry to measure Dyne proprietary drugs in.
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Perform non-destructive testing techniques at industrial facilities, including ultrasonic, magnetic particle, liquid penetrant, and visual inspections. Nova Data Testing is currently looking for hard-working and dependable experts as Non-Destructive Testing Technicians to support our projects in the South East and the New England regions.
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Oversee and ensure quality control of the pathology team’s methods and data from internal and external labs to support primary, secondary and exploratory endpoints in clinical trials under regulated approaches (GLP, GCP.
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Amgen is currently seeking a Process Development Sr Principal Scientist in our Pivotal Attribute Sciences Department in Cambridge, MA. This team plays a crucial role in pivotal phase analytical development, including method development, validation, transfer, process and product development support, and GMP testing of drug substances and drug products.
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Thorough end-to-end testing of the Alpha platform and all applications, data, and operational workflows - across State Street, our clients, and our partner organizations (including Charles River Development) - is critical to reducing implementation timelines, to providing reliable and consistent delivery of data and functionality at time of system cutover, and to delivering a seamless and repeatable implementation experience to our clients.
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We are looking for an outstanding Quality Assurance Engineer – Requirements, Test Plans & Reports, who will convert functional requirements into test-plans for the QA Manual Testing team to execute, and summarize learning in Validation Test-reports.
$95,700 - $177,900 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Partners with all line functions to ensure GMP, GLP and GCP compliance for all clinical development programs by providing guidance and serving as an expert in the interpretation regulatory requirements and expectations.
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Lead identification of assay requirements, lab selection, and contract development to ensure regulatory compliance according to GLP, GCP, and applicable global regulatory requirements such as CLIA and EU IVDR, and execution feasibility.
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Performs Bio-Analytical testing such as Flow Cytometry, ELISA, qPCR, cell count, (incoming, in-process and final product release testing). Experience in gene therapy cGMP manufacturing and testing.
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Knowledge of some of the following technology domains: Penetration Testing, Vulnerability Scanning, ITSM, CMDB, and Firewalls. An understanding of red teaming, penetration testing tools/techniques and threat hunting.
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O BS/MS Analytical Chemistry, Biochemistry, Biophysics, or a related discipline with at least 4 years of hands-on experience working with LC-MS based assays is in R&D / GLP/ cGMP environment is must.
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Conduct interest rate risk measurement and liquidity stress testing using the Empyrean Solutions software. Experience with Empyrean ALM and Liquidity Stress Testing models is strongly preferred.
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Support Chief Fiduciary Officer in managing internal audits, regulatory exams, compliance testing, and control testing. Support Chief Fiduciary Officer team in enterprise and interdisciplinary Wealth Management projects/initiatives.
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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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glp testing jobs Title: associate Company: Aequor in Boston, MA
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