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The individual in this role will collaborate closely with research, process development, manufacturing, regulatory, and quality to develop and innovate Vertex next generation Cell and Gene Therapy products.
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This role will work collaboratively with the Manufacturing, Process Development, Regulatory, and Quality functions to both provide high quality data to drive strategy and decisions as well as develop and innovate next generation analytical automation tools for the characterization of cell and gene therapy processes and products.
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The individual will be responsible for helping to drive the on-time-delivery of manufacturing start-up activities for all aspects of cell therapy manufacturing and, contribute to on-time-delivery of manufacturing operations for ElevateBio's multiproduct cGMP cell and gene therapy site.
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Experience with the regulation of biologics is essential; experience with gene editing and/or cell and gene therapy is preferred. Bachelor's degree (BA/BS) in a scientific discipline required and advanced degree preferred with a minimum of 10 years' experience in drug development/regulatory affairs and a minimum 8 years in CMC regulatory affairs.
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Hands-on experience with gene and cell therapy test methodologies including cell culture, Flow Cytometry, ELISA, MSD, ddPCR, and cell-based assays. ElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine.
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Ginkgo is looking for a highly motivated Senior Downstream Production Engineer, Cell and Gene Therapy to join the Foundry’s expanding High-throughput Screening (HTS) team. PhD in Pharmaceutics, Biotechnology, Biomedical Engineering, Chemical Engineering, Biology or related field with a strong background in gene therapy-based drug product development and 3+ years industry experience.
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Hands-on experience in tissue culture, plate-based assays, RNA isolation, gene expression analysis (qPCR), western blot, ELISA, multiplex protein analysis, flow cytometry preferred. Perform molecular techniques including DNA/RNA isolation, PCR, qRT-PCR, gene expression analysis, cell line engineering and tissue culture as needed.
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Collaborate with business stakeholders and suppliers extensively on developing and implementing risk and resiliency strategies to ensure continuity of supply for innovative product pipeline, and expanding market footprintRegulatory Compliance, Stay abreast of regulatory requirements and industry standards related to cell and gene therapy sourcing.
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Analytical Skill, Analytical Skill, Analytical Thinking, Chemical Biology, Chemistry, Clinical Trials, Collaboration, Communication Skills, Curiosity, Data, Data Analysis, Design Of Experiments, Detail-Oriented, Drug Development, Drug Discovery, Ethics, Gene Therapy, Immunology, Inventory Management, Laboratory, Lifesciences, Machine Learning (Ml), Management, Medical Research, Molecular Biology {+ 10 more.
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Maintain awareness of the current state of the field (literature, regulatory expectations, and competitive surveillance), and contribute to the broader cell and gene therapy industry and academic ecosystem through publications and conference presentations.
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Development of spectroscopic methods (Raman, NIR, FTIR) for process monitoring of biologics such as mAbs, proteins, viral vaccines, or gene therapy vectors. Understanding of bioprocessing, gene therapy process development, characterization, and manufacturing.
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The candidate must be detail oriented, have excellent record keeping and communication skills, and be willing to work in a dynamic entrepreneurial environment with a deep interest in bringing a new type of gene therapy to patients.
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The candidate will perform literature search about the newest trend and technology in Cell and Gene Therapy development, majorly focused on finding a way to make stable inducible host cells line to product viral vectors.
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Strong understanding of the Pharma and Biotech industry challenges is needed and ability to develop high level of applications knowledge based on industry and familiarity with most common Sequencing, Synthetic Biology, cell and gene therapies, and molecular biology lab techniques.
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Demonstrable track record of selling or supporting solutions for molecular biology including CRISPR gene editing, molecular cloning & mutagenesis, gene assembly, or next-generation sequencing.
$100,000 - $200,000 a yearFull-timeExpandApply NowActive JobUpdated Today
consumer affairs gene therapy jobs Title: regulatory affairs in Boston, MA
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