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Work with the BST network of specialty labs to support delivery of high quality bio analytical and biomarker data to clinical programs, ensuring adherence to the requirements of quality, and ethical and regulatory standards, including ICH/GDPR/GCP/IVDR/GLP.
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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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Preference to candidates with GLP and / or GVP experience in addition to the required GCP background. These activities include the operational quality oversight of the clinical development programs specifically within our Cell and Gene Therapy (CGT) Disease Areas of the clinical portfolio.
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Under the direction of the TS Manager/Supervisor may be responsible for packing and shipping sentinel animals to Charles River Laboratories for diagnostic testing. This includes accurate sentinel animal identification (room/rack #) for scheduled shipment to Charles River Laboratories for pathogen testing.
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Performs Point of Care Testing (POC) as ordered including Urine dips, HCG testing, Strep A, HGB A1C, and glucose testing. Assists in arranging for diagnostic testing, surgery and in-patient admissions under direction of the nurse or physician.
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The Scientist, Analytical Development & Quality Control is responsible for analytical development, feasibility, method qualification, routine, and stability testing of antibody drug conjugates and intermediates.
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The Associate Director of Analytical Development will lead a team of analytical scientists responsible for development, manufacturing, release and stability testing, and characterization of drug substances/API and drug products of Small Molecule and Oligonucleotide therapeutic modalities within the Strategic External Development (SED) organization.
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In this role, you will be responsible for analytical testing (cell and molecular biology assays) as well as excursion/deviation investigations and reports in support of ElevateBio’s gene and cell therapy programs.
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Oversee integration testing of EOTSS Single Sign On (SSO), EOTSS Identify Access Management (IAM), EOTSS Multi-Factor Authentication (MFA), Cloud SaaS Vendor user access management, and Comptroller's access controls and provisioning processes.
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Collaborate with external suppliers for PCB layout, fabrication, assembly and testing. Collaborate with mechanical and controls engineers on electrical/thermal/packaging design, integration and testing.
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POSITION SUMMARY: Under supervision of the Operations Manager and according to established policies and procedures, provides direct patient assessment and management in the BMC Stress Testing Laboratories and/or Cardiac Rehabilitation & Prevention Program.
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Keeps current regarding development in technical instrumentation to trends and techniques in cardiac ultrasound testing through appropriate journals attends seminars and other meetings per approval of echo supervisor.
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Own complete circuit development process for cutting edge applications in robotics: Specifications, analysis, simulation, design (Schematic & Layout), programming, prototyping (vendor management), testing, and documentation.
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Job Overview: The Director of Analytical Development will lead the creation and execution of strategies for high-throughput, high-quality testing of iPSC Cell Therapy products, developing analytical methods and streamline method development and transfer processes.
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Establish relations with CROs to execute on the biomarker strategy, monitor assay development including qualification/validation and biomarker testing in clinical trials to ensure high quality biomarker data.
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glp testing jobs Title: analytical Company: Pci Services in Woburn, MA
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