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Demonstrated experience with biochemical assay development and optimization. Apply in-depth molecular biology knowledge and experience in the development of CRISPR-based molecular diagnostic assay systems, including development of enzyme reagents and assay workflows.
$105,000 - $135,000 a yearFull-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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With a role central to the evaluation of alternative target enrichment platforms, including NGS-based and qPCR-based systems, you will also drive assay optimization and perform clinical validations.
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Perform all aspects of antibody development including screening and characterization, assay design, and preclinical development using small animal models of infection. Lead the antibody discovery and optimization team to apply translational immunology and other preclinical assays to support pipeline program progression for microbial pathogens of military relevance, including ESKAPEE pathogens.
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Job Responsibilities:Assay Optimization and Validation: Conduct in silico analysis of genomes and primers/probes, followed by optimization of reaction conditions to enhance assay sensitivity and specificity.
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As part of the Regulatory Bioanalysis Team in Integrated Bioanalysis (iBA), you will be responsible for supporting pharmacokinetics (PK), cellular kinetics (CK), immunogenicity and biomarker assay development, optimization, qualification/validation as well as the execution of high complexity assays using state-of-the-art instrumentation to support pre-clinical and clinical studies for a variety of modalities including bispecifics, T-cell engagers, & cell and gene therapies.
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Supporting the work of the assay development team by leading the analysis of datasets generated as part of ongoing technology development and protocol optimization. Reporting to the VP of Computational Biology, the Director, Computational Biology will interact closely with the core R&D team and be responsible for developing and implementing computational models and algorithms to analyze complex biological data sets and support assay development and collaborations with Key Opinion Leaders in academia and industry.
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Experience with MoA, functional, or potency assay development is preferred. Perform development, optimization, robustness, and qualification of cellular and molecular assays used for lot release and characterization of cell and gene therapy products and critical materials.
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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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Proficiency in programming languages commonly used in bioinformatics and computational biology, including R and Python. Strong background in molecular biology, cellular biology, genetics and/or biochemistry, with a solid understanding of biological principles and experimental techniques.
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As a Scientist on the in vitro Pharmacology team, you will be an integral part of our research and development efforts, leading bioanalytical support functions and assay development. Contribute to the development and optimization of gene therapy manufacturing processes.
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Tasks will include, but are not limited to assay feasibility, assay development, optimization, reagent formulation, guard band and stability studies, sample testing, and assay verification studies.
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The Quality Control Analyst will work within the QC team, testing gene therapy products utilizing cell-based assays (Potency assay) in support of clinical and commercial lot release and stability activities.
$72,000 - $90,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Assisting pharmaceutical and biotech customers with product optimization, assay development, stability analyses, and manufacturing improvements. You will also support non-clinical work in the pharmaceutical and biotech industries, so experience with assay development, immunogenicity assessment, and manufacturing are a plus.
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In addition to assay development and fit for purpose mechanistic studies, this role focuses on the application of novel methodologies to the in vitro and ex vivo studies conducted by Safety Assessment as well as support for routine toxicology assay screening for drug discovery programs.
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Experience in immunoassay product development nice to have but not required, 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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