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Development, optimization, qualification, transfer, validation, and routine execution of analytical methods for proteins, mAbs, drug conjugates using techniques pertinent to LC (SEC, RP, IEX), LCMS, ELISA, CE-SDS, icIEF, and other wet chemistry techniques.
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Collaborate with Supplier Quality team in their communication with material suppliers, related to the development and validation of detailed material specifications for new materials, and the resolution of any quality issues.
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Advanced degree (BS, MS or PhD) in Chemical/Biochemical Engineering, Biochemistry, Immunology, or related degree with experience (8+ for BS, 5+ for MS, 2+ for PhD) in process development and manufacturing sciences in cell therapy, biotechnology, or pharmaceutical industry.
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Reporting directly to the Senior Vice President of Strategy & Sustainability and working with various strategic partners across the Groups and the wider Veralto Strategy and Corporate Development organization, this highly visible role is instrumental in shaping the strategic direction and inorganic growth trajectory of the enterprise and driving shareholder value.
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The position is responsible for product development, technology transfer and overall management of CMC activities related to ensuring robust development and reliable GMP supply of oligonucleotide conjugates and intermediates.
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Experience in immunoassay product development strongly desired, including reagent development and optimization, assay protocol optimization, migration of manual assays to automated instrumentation, specifications development, statistical methods, verification and validation protocol writing and execution, conformance with design control regulations.
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Prior management of contract research organizations (CROs) for clinical biomarker assay development and qualification. Prior experience implementing precision medicine approaches in clinical trials including companion diagnostic (CDx) development experience in liquid-based and tumor tissue-based approaches.
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The Humanitarian Assistance & Disaster Relief Systems Group develops, adapts, and deploys advanced technologies to address the most significant challenges in humanitarian assistance, disaster relief, global development, community resilience, and climate change.
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Our solutions span use cases across the product life cycle, from product development to mass production and aftermarket operations, and they address an array of industries, including automotive, aerospace, healthcare, consumer products, heavy industry, machine design and research and development.
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As a Business Development Manager, you'll meet with customers, facilitate new business opportunities, and develop and execute capture strategies. Progressive experience with technical marketing, proposal development, and program management or engineering design.
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Employ CBA data visualization and editing tools to aid in the efficiency of gap analysis in CBA development, generating Joint Capabilities Integration and Development Systems (JCIDS) products, and provide a persistent data model that will reduce the need to re-create data across multiple program documents, and will feed requirements documentation, allocation, and tracking tools such as Dynamic Object-Oriented Requirements System (DOORS.
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Expertise in primary human cell culture, multi-color flow cytometry, multiplex cytokine detection, functional immune cell assays (proliferation, cytotoxicity, chemotaxis) and assay development is essential.
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We are seeking an experienced, high caliber Senior Electromechanical/Mechatronics Engineer to collaborate with teams in designing and developing complex electro-mechanical medical devices and test equipment to support critical aspects of our product development pipeline.
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Liaise with Analytical Development, Process Development, Alkermes QPs, other QA teams, to resolve any discrepancies noted during analytical and batch record review. Responsible for ensuring development programs are operating in compliance with the EU/FDA regulatory requirements and in compliance with company standards.
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Must meet the Magellan MFLC CYB criteria for experience with children and youth and specialty in child and adolescent development/psychology. These services may include non-medical counseling, training/health and wellness presentations, consultation with parents, personnel at child development centers, and consultation to installation command regarding behavioral health issues affecting children and youth.
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development job Title: software eng Company: Amd in Concord, MA
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