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Scientist I - Immunology - Gene Therapy Research Sarepta Therapeutics is seeking a motivated and creative individual to work in a key drug discovery group in our research organization and play a central role in gene therapy drug developme.
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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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The NCH Center for Gene Therapy has a long track record of training leaders in gene therapy, has been the site of the development of the first FDapproved AAV-mediated gene therapy for neuromuscular disease (SMA.
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2 years of experience understanding genetic mutations and their impact on the biological functionality of proteins, experience with genetic medicines including gene-therapy, gene-editing, cell therapy, mRNA and RNA silencing experience with pharmacokinetic, pharmacodynamics data and safety data.
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8-10+ years in pharma or biotech industry (Gene or Cell Therapy), including at least 5 years leading a Medical Affairs organization (Ophthalmology experience preferred) Adverum is a clinical-stage gene therapy company targeting unmet medical needs in ophthalmology and rare diseases.
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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 in cGMP cell therapy and/or biological product manufacturing, preferably with emphasis on immunological systems, cell/gene therapy, and individualized patient therapies is desired.
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The Manufacturing Associate will play an essential role in supporting manufacturing operations, ensuring compliance with regulatory standards, and contributing to the advancement of cell and gene therapy products for patient treatment.
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Strategic global enterprise leader to capture untapped potential to drive business growth, develop and drive execution of strategy and elevate market presence for the Global Therapy Innovations (GTI) Business Area. The role focuses on filling a growth pipeline considering the full continuum of care in the Cell and Gene Therapy market - from cell collections to manufacturing and delivering final product.
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We are seeking a highly skilled and motivated Senior MES Engineer with 3-5 years of experience in Emerson Syncade MES, specifically in the Biologics, Pharmaceutical, or Cell and Gene Therapy industries, to join our team.
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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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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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The Regulatory Affairs Specialist will provide regulatory support for the Catalent Cell and Gene Therapy sites. This position will evaluate facility change controls for compliance with applicable change control guidance and will maintain site master files and Type V DMFs. In addition, the Regulatory Affairs Specialist will provide audit support and assist in preparing for group meetings and communications as appropriate.
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consumer affairs gene therapy jobs Title: regulatory in Anoka, Minnesota
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