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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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Provide strategic medical and scientific leadership across all R&D stages from preclinical through regulatory approval for gene therapy programs. - Provide strategic medical and scientific leadership across all R&D stages from preclinical through regulatory approval for gene therapy programs.
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Experience working in gene therapy, gene editing/CRISPR, and/or RNAi required. Experience working in gene therapy, gene editing/CRISPR, and/or RNAi. By enabling precisely targeted, highly efficient, manufacturable off-the-shelf in vivo delivery, Kelonia s technology has the potential to revolutionize gene therapy and dramatically expand the impact and reach of genetic medicines to every patient in need and can be applied to a broad range of diseases.
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We became a wholly-owned, independently operated, subsidiary of Bayer AG in late 2020 as a cornerstone of its newly formed Cell & Gene Therapy (CGT) platform. Asklepios BioPharmaceutical, Inc. (AskBio) is a leading, clinical-stage gene therapy company founded in 2001 based on the work of adeno-associated virus (AAV) gene therapy visionary and pioneer, Jude Samulski, PhD. Since that time, our commitment to developing life-saving medicines that can potentially cure genetic diseases has never wavered.
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Participate in training programs and stay updated with current industry trends, regulatory requirements, and advancements in gene therapy manufacturing processes. As a Technician I, GMP Manufacturing - Upstream you will play a critical role in the production and cultivation of AAV-based gene therapy products in compliance with current Good Manufacturing Practices (cGMP) regulations.
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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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Lead analytical development and quality control for AAV gene therapy, small molecules, antisense oligonucleotides, mRNA and protein therapeutics. Modalities include AAV gene therapy, small molecules, antisense oligonucleotides, mRNA and protein therapeutics.
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ElevateBio is looking for a Cell Therapy Manager, QA Operations to join their growing Quality Group at our BaseCamp facility in Waltham, MA. In this role, the Manager will be primarily responsible for providing Quality oversight over execution of clinical cell and gene therapy manufacturing for cGMP compliance through on the production floor interactions, review and approval of batch related documents, and events.
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Keywords: Regulatory, IND, CTA, SharePoint, Gene Therapy, Cell Therapy, Biotechnology, FDA, Pharmaceutical, Regulatory Submission. Piper Companies is currently seeking a Sr. Regulatory Operations Specialist to support a growing and innovative cell and gene therapy company in Philadelphia, PA (Hybrid Schedule.
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A strong understanding of molecular biology techniques for analysis of gene therapy products: to include (but not limited to) PCR, Infectivity, Potency, and various ELISA methods. The Alachua manufacturing site is part of Ascend Advanced Therapeutics, a gene therapy CDMO. Ascend is a specialist AAV development partner working to support the next-generation of life-science innovators in bringing gene therapy products to patients.
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Upstream Bioprocess - Technical Services/Manufacturing Scientist (TS/MS) role is responsible for providing technical support for the development, implementation, and technical transfer of compliant manufacturing of gene therapy drug substance and drug product for clinical and commercial manufacture.
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As Gene Therapy Manufacturing Supervisor / Lead, you will play a critical role in helping to establish REGENXBIO's first internal GMP BDS and FDP clinical and commercial AAV gene therapy manufacturing capability.
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Must have direct experience in Regulatory Affairs CMC for biologics/vaccines or cell and gene therapies, with a demonstrated track record of significant accomplishments (e.g. successful IND, leading health authority interactions on CMC topics.
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Validation Engineer 3 (Gene Therapy Program) The Gene Therapy Program (GTP) is entering a new era of unprecedented opportunity with the great potential to reshape the face of medicine, as we know it.
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Lead the collaboration with IDT Product Marketing/Management, Product Development, and Project Management - as well as with Global Sales and Regional Marketing - to develop accurate marketing personas, effective customer segmentation strategies, insightful buyer journeys, and useful value propositions and key messages specific to the cell and gene therapy market segment.
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consumer affairs gene therapy jobs Title: regulatory affairs in Anoka, Minnesota
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