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Vector Core. The rAAV vectors manufactured support capsid technology development, intellectual property portfolio and progression of internal and external early-stage gene therapy programs.
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Experience with biosafety assessment of raw materials, viruses, and cell lines used for gene and cell therapy products, including preparation of regulatory filings and responses to questions from health authorities.
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The ideal candidate will have knowledge of the evolving fields of molecular biology, biochemistry, pharmacology, toxicology, and medicinal chemistry, and experience with GMP scale-up, large molecules, cell and gene therapy approaches, and regulatory affairs.
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The Full Project Scientist candidate will perform independent research on clinical trials of hematopoietic stem cell gene therapy (HSC-GT) for primary immune deficiency diseases and hemoglobinopathies.
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In this role, the Molecular Biology Quality Control Analyst I will be responsible for supporting the gene therapy program pipeline, including but not limited to routine GMP testing of AAV vector analytical methods such as GC titer determination by ddPCR and qPCR, impurity testing, and other methods as needed.
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Experienced with analytical test methods used for cell/gene therapy (e.g. flow cytometry, cell-based assays, PCR, and ELISA test methods) 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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We are global leaders in providing products and services within the fields of nucleic acid production and biologics safety testing to many of the world's leading biopharma, vaccine, diagnostics, and cell and gene therapy companies.
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Resilience.com Position Summary: We seek an experienced Analyst, QC Bioassay / Biochemistry to support establishing new commercial-level in-house GMP testing laboratories performing release and stability testing for multiple stages of our gene therapy and immune oncology products.
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Champion the advancement of the AAV viral vector production and purification platform through creative solutions including technology scouting and DoE experiments to accelerate gene therapy programs.
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Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. Associate of Science or Bachelors degree preferably in Biochemistry, Chemistry, Biology or related field or.
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Masters degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or related field and 3+ years of experience in a manufacturing environment; OR. Bachelors degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or related field and 5+ years of experience in a manufacturing environment; OR.
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Support method development, transfer and qualification/validation activities associated with the cell-based potency assays for AAV-based gene therapy products. 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.
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Applicants should have a PhD degree or an MD with post-graduate scientific training, and at least three years of research experience in relevant areas such as Molecular Biology, RNA biology, Biochemistry, animal modeling, Immunology, Gene Therapy, Cell Therapy, Bioengineering, Neuromuscular Biology, Cell Biology, and Virology.
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GenScript ProBio is the subsidiary of GenScript Biotech Corporation, proactively providing end-to-end CDMO service from drug discovery to commercialization with proactive strategies, professional solutions and efficient processes in cell and gene therapy (CGT), vaccine, biologics discovery and antibody protein drug to accelerate drug development for customers.
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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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