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The individual will focus and work along a group of scientists to develop small- and large-scale lentiviral vector (LVV) gene therapy vectors across various preclinical programs and disease areas.
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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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Prior experience in gene therapy products or biologics, demonstrating the ability to navigate the unique challenges of pharmacovigilance in these areas. Lead a cross-functional project focusing on the development of guidance for the long-term safety assessment of gene-editing products, ensuring compliance with regulatory requirements and best practices.
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Strong understanding of biologics, including but not limited to vaccines, blood, or blood components, allergenics, somatic cells, gene therapies, tissues, recombinant therapeutic protein, and living cells used in cell therapy.
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4 to 5 years experience in related cGMP environment; Biologics, Cell Therapy, Pharmaceutical. Excellent verbal and written communication skillsTechnical understanding of biopharmaceutical production, with experience in cell and gene therapy a plus.
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The ideal candidate is an experienced within Quality Assurance Operations with a track record of success in GMP environments who understands biologics processes (i.e. cell & gene therapy, aseptic environments, reagent control, contamination control.
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Demonstrated expertise understanding/interpreting regulatory guidance on cell and gene therapy products required. A working knowledge of cGMP requirements in clinical or commercial biologics required.
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Maravai LifeSciences will never interview a candidate over RingCentral, similar messaging apps or social media (e.g. Telegram, Google Hangouts, WhatsApp, Facebook Messenger, etc.) Advanced Statistical Knowledge : Proficiency in statistical analysis tools (e.g., R, Python, SPSS) as well as visualization tools (Tableau and Salesforce.
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As CMC Manager, Global Regulatory Affairs, you will be responsible for Chemistry, Manufacturing and Controls (CMC) regulatory activities related to product registration in international markets and license maintenance for assigned products of the Cell and Gene Therapy (CGT) portfolio.
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We are seeking an experienced, highly motivated, collaborative, and curious Senior Research Associate/Assistant or Research Scientist to join our gene and cell-therapy team within Calibr-Skaggs Institute.
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Calibr-Skaggs is seeking a talented Research Scientist in gene and cell therapy/immuno-oncology to join our effort to create a transformational gene and cellular therapy approach.
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Apply biology and virology expertise to design and test gene expression plasmids for our gene therapy platform. Evaluate and implement innovative approaches to optimize viral vectors backbones, transgenes, promoters and other elements to support our gene therapy pipeline programs.
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Understanding of the manufacture and testing of biologics and/or cellular and gene therapies is desirable. These include, but are not limited to, the FDA (Food and Drug Administration), state departments of health, state laboratories, blood and tissue regulators, Foundation for the Accreditation of Cellular Therapy (FACT) and CMS (Center for Medicare and Medicaid Services) / CLIA (Clinical Laboratory Improvement Act.
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For a Contract Development and Manufacturing Organization (CDMO) will play a crucial role in ensuring the highest standards of quality and compliance are maintained throughout the cell and gene therapy manufacturing process.
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Previous experience with one or more cell and gene therapy modalities (e.g. viral vectors, autologous cell therapies, plasmids) CARGO is currently evaluating its lead program, CRG-022, an autologous CD22 chimeric antigen receptor (CAR) T-cell therapy candidate, in a potentially pivotal Phase 2 clinical trial in patients with large B-cell lymphoma (LBCL) whose disease relapsed or was refractory (R/R) to CD19 CAR T-cell therapy.
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