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This is a multidisciplinary role & this individual will further interface across many parts of the company to develop novel products used in the cell therapy and gene therapy world.
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You will have demonstrated experience, leadership, and independence with QC functions associated with the GMP production and testing of cell/gene therapy products or biologics in both clinical and/or commercial settings.
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Based on our innovative approach to developing genetic medicines, as well as our industry-leading internal manufacturing capability and expertise, we have become the Astellas Center of Excellence for their newly created Genetic Regulation Focus Area. We are currently exploring three gene therapy modalities: gene replacement, exon skipping gene therapy, and vectorized RNA knockdown, with plans to expand our focus and geographic reach under Astellas.
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Is a leading global cell and gene therapy contract, testing, development, and manufacturing organization (CTDMO) that is dedicated to advancing the development and commercialization of cell and gene therapies.
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This role will provide support for the manufacturing of gene modified autologous T-cell product at our manufacturing site in the Philadelphia Navy Yard. The Specialist will perform cell processing activities, media formulation, product sampling, and other manufacturing needs as necessary, commensurate with the level of training and experience of employee.
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Working knowledge of gene-based therapy approaches (gene regulation, RNA medicine, gene therapy) is desirable. Strong background in quantitative and qualitative research methodologies related to systems biology, pharmacokinetics, and PK/PD.
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FL87, Inc. is a privately held, early-stage biotechnology company developing a novel approach to gene therapy that can address currently untreatable diseases. Molecular biology experience with experience in enzyme processes and optimization, IVT and/or other isothermal amplification, and PCR.
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Minimum of 5 years in a client-facing sales role in the life sciences industry, with preferred experience in the biopharma industry selling into the cell and gene therapy client segments, with proven track record of being a top performer.
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Broad technical understanding in the field of molecular and cell biology, with a clear understanding of biotherapeutics, including nucleic acids, gene editing, DNA plasmids, mRNA therapeutics, viral vector technologies, CAR-T, etc.
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Generous recruitment awards are also available on a competitive basis from CPRIT. DLDCCC is composed of 7 outstanding research programs including Nuclear Receptor, Transcription and Chromatin Biology, Pediatric Oncology, Cancer Prevention and Population Science, Cell Signaling and Metabolism, Mechanisms of Cancer Evolvability, Breast Cancer, and Cancer Cell and Gene Therapy.
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Experience with molecular biology techniques, especially those directly related to ddPCR or qPCR (e.g., DNA extractions, PCR, column-based purifications) Process Development, ddPCR, qPCR, cell culture, cell-based assays, CAR-T cell separation, cell enrichment, cell expansion, gene editing, formulation.
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Requirements Requirements, Knowledge, Skills, and Abilities:Ph. D. in a scientific discipline (e.g., molecular biology, cell biology, or related field) with 0-2 plus years of hands-on experience with gene editing, site-specific nucleases (especially RNguided nucleases), transposons, or other vectors used in vivo or in vitro, is required.
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The ideal candidate will have experience in molecular biology and biochemistry (e.g. molecular cloning, western bloting, qPCR, various in vitro assays, and cell culture), as well as show talent or promise in scientific writing.
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The successful candidate will work closely with AstraZeneca laboratory groups within IBA and our vendor partners to ensure appropriate bioanalytical and platform strategies, scientific oversight and delivery of our cell and gene therapy pipeline while fostering an environment of scientific knowledge exchange.
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The Hearthis the home ofa custom-designed cGMP facility dedicated to AAV viral vector manufacturing and will host end-to-end manufacturing services to accelerate gene therapy programs from preclinical through clinical and commercial stage manufacturing.
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