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Its patent-pending and proprietary pluripotent stem cell differentiation technology platform TFome™ was developed in Professor George Church’s lab, a pioneer insynthetic biology, and allows for the development of unique cell therapies with significantly streamlined manufacturing, improved cell quality, efficiency, and speed.
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In this key role, you'll lead the development and production of high-quality media and cell therapy intermediates, as well as drug products, to support our Cell and Gene Therapy projects.
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Guide method development, validation, and sample testing of bioanalytical methods to ensure generation of quality scientific data and meet program timelines. Strong background and successful track record in bioanalytical assay development, optimization, and troubleshooting with experience in: transcriptomics, pharmacogenomic analyses and interpretation, biomarkers (including pharmacodynamic biomarkers), flow cytometry, PK, ADA, and nAb methods.
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Reporting to the COO, The Vice President, GxP Quality Assurance is responsible for establishing and leading Aveo’s Quality Management System (QMS) operations and ensuring compliance with Local, State, Federal, and International regulations and standards associated with GXPs and Quality Systems in a fast-paced, primarily virtual development environment.
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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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The Alloy Global Bioanalytics group provides bioanalytical support to all Alloy activities, including assay development, quality control and high-throughput characterization of antibodies, TCRs, TCR mimics and.
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Units within UA include development/fundraising, alumni engagement, stewardship and donor relations, special events, gift processing, research and prospect management, gift planning, corporate and foundation relations, and information systems and management.
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Who will own and drive execution of our analytical development roadmap with the aim of establishing capabilities to test Induced-Pluripotent-Stem-Cell (iPSC) clones at a high level of throughput and quality.
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JOB OVERVIEWThe Senior Development Associate (SDA) provides donor relations and administrative support to the Major Gifts team connected with all fundraising, stewardship, and cultivation activities.
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Job Title Research Associate
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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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Technical lead of analytical method development for nucleic acids, lipids, & lipid nanoparticles as part of development of FL85 platform, product, process, and formulations. FL85 is seeking a Director of Analytical Development to join our team to lead development of assays focused on CMC development of products based on FL85's novel technology platform.
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Owns and performs strategic planning, goal planning, budget planning and management, performance review, professional development, and all other senior-level managerial functions for all Quality & Controls Assurance Programs, functions, and teams.
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Company, Lexington, Massachusetts (Remote) Purpose and Scope: Responsible for applying biomedical systems engineering and quality assurance principles and techniques to NxStage’s product development lifecycles, focusing on design assurance for product development projects.
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Functional Leadership: Lead the design, development, optimization, and execution of high-quality in vitro pharmacology assays to evaluate the activity, mechanism of action, and efficacy of Cell Therapy products.
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development quality jobs Company: Pnc in Winchester, MA
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