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Conduct Quality Control Analtyical testing (e.g., ELISA, Flow Cytometry, PCR) of patient samples, stability samples, controls, and reagent qualification in a GMP environment. Conduct some laboratory testing (e.g., ELISA, Molecular Biology)Troubleshoot instrumentation and test methods.
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Our laboratory service offerings include immunohistochemistry, FISH, CTC isolation and characterization, chemosensitivity testing, tissue procurement, flow cytometry, ELISA, mutation testing, cell expansion, and colony-forming assays.
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Strong expertise in cell culture techniques and developing/qualifying cell-based assays, including ELISA and ddPCR methods. Lead the development and qualification of diverse cellular assays, including ELISA (Enzyme-Linked Immunosorbent Assay) and ddPCR (droplet digital PCR), to characterize and release human pluripotent and hematopoietic stem cells.
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Small-scale adenovirus production in mammalian cell culture and virus purification by AKTbased IEX chromatography. Performing a range of viral titration and QC assays including ddPCR, viral potency measurements, PAGE/ agarose gel electrophoresis, western blotting, DLS/DSF, and ELISA.
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Experience with bacterial cell culture, molecular or biochemical assays (PCR, ELISA) and protein purification. We are partnered with a clinical stage, cell therapy company located in Philadelphia, who due to growth are looking to expand thier team with an Associate Lab Manager.
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Extensive experience performing basic analytical assay techniques: absorbance assays, SDS-PAGE, chromatography, CE-SDS, ELISA, western blot, cell-based potency assay. Cell-Based Potency Assays : While not a mandatory skill, experience with cell-based potency assays is advantageous and can substitute for ELISA expertise.
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Manages studies with highly technical components and expanded endpoints such as Immuno-oncology and Hematological studies involving ex-vivo analyses including but not limited to 2D/3D cell assays, Luminex, ELISA and flow cytometry.
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Perform cell type differentiation, characterization and experimental endpoint analysis including flow cytometry, ELISA and microscopy. Its patent-pending and proprietary pluripotent stem cell differentiation technology platform TFome™ was developed in Professor George Church’s lab, a pioneer in synthetic biology, and allows for the development of unique cell therapies with significantly streamlined manufacturing, improved cell quality, efficiency and speed.
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With analytical techniques, such as QPCR, PCR, SDS-PAGE, Western blotting and ELISA - Exp. with electronic laboratory notebook applications, such as Benchling - Basic knowledge and application of theories, principles and techniques in molecular biology and cell biology "Nice to Haves": - Experience in a QC/GMP testing environment a plus Duties/Responsibilities: - Operate and maintain standard laboratory equipment and department-specific equipment.
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Strong experience managing external manufacturing operations at CMO's/CRO's/CDMO's in relation to bioassays such as ADCC, CDC, ELISA, SPR (Crucial), and Cell-based binding assays. Provide oversight and expertise for external manufacturing operations relating to bioassays such as ADCC, CDC, ELISA, SPR, and Cell-based binding assays.
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Extensive expertise in analytical development and troubleshooting related to biologics, with proficiency in various methodologies such as chromatography, immunoassays, residual analysis, and cell-based assays.
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Strong technical skills or expertise in several of the following areas (ranked by importance): cell culture and transfection, RNA/DNA isolation, quantitative PCR, ChIP, CRISPR, immunohistochemistry and imaging, ELISA/Luminex/MSD, western blotting.
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Experience with aseptic cell culture technique is required and hands-on skills in basic immunological assays is strongly preferred (e.g. multi-color flow cytometry, primary cell culture, functional cell based assays, ELISA, Western blot, MSD, Luminex.
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Hands-on experience with immunology and cell biology techniques (multi-color flow cytometry, RNA/DNA extraction, PCR, Western Blot, ELISA, small molecule/biologics interventional assays.
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The Associate Director, QC Cell Culture and Bioassay will be responsible for overseeing a testing laboratory charged with the execution of all GMP bioassay testing (release and stability) related to Sarepta' s Gene Therapy pipeline.
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