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This individual is a subject matter expert in the implementation and management of Quality Management Systems and has a comprehensive understanding of Clinical and Product compliance requirements for gene therapy products.
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Here at Kelonia Therapeutics, we aren’t just a preclinical company; we’re trailblazers in viral engineering, pushing the boundaries of in vivo lentiviral gene and cell therapy. At Kelonia, we've gathered a group of pioneers in cell and gene therapy to lead our journey, with extraordinary scientific founders at the helm, providing the cutting-edge technology that sets us apart.
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Desire and drive to increase access of cell and gene therapy products and passion for their impact on the lives of patients with serious diseases. Monitor internal and external clinical manufacturing up to process performance qualification (PPQ), identifying and managing implementation of process improvements and change controls, managing process deviations and out of specification investigations through approved quality systems for manufacturing of gene-delivery raw materials.
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The Quality Assurance (QA) Manager is responsible for maintaining Food Safety and Quality Assurance Management Systems to support manufacturing of wholesome and quality food.
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Astellas is announcing a Senior Validation Specialist, Quality Assurance opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA. Purpose:The Validation Specialist, Quality Assurance, will provide QA oversight of commissioning, qualification and validation support to M-TC’s cGMP Cell Therapy Manufacturing facility as the products move through clinical trials and commercialization.
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Extensive knowledge of regulatory requirements and quality standards for cell and gene therapy products. Develop and implement strategic plans for product development, analytical development, and manufacturing to support the company's gene therapy pipeline.
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Manage the Quality Control and Assurance program for Project reporting administratively to Project Manager and functionally to Quality Director. Prepare weekly and monthly reports to Project Manager / Client / Quality Director.
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Minimum of 2 years of experience in gene therapy AAV upstream/downstream AAV vector production processes or bacterial fermentation and plasmid amplification, including related technologies as described in the responsibilities section.
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The Quality Assurance (QA) Manager - GXP Computer Systems ("QA Manager") will join the Civica, Inc. ("Civica") team in supplying essential generic and biosimilar quality medicine by bringing their knowledge and experience to serve patients and pursue excellence in quality and compliance.
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Performs necessary physics support for all aspects of therapy quality assurance including but not limited to: 3D and IMRT/VMAT (Intensity-Modulated Radiation therapy/Volumetric-Modulated Arc Therapy) treatment planning, SRS/SBRT (Stereotactic Radiosurgery/Stereotactic Body Radiation Therapy),DIBH (Deep Inspiration Breath-Hold), and Respiratory Gating.
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CGMP manufacturing experience, preferably cell/gene therapy, with experience in tech transfer, process validation, project management, and change management. Cell/Gene Therapy and CDMO experience preferred.
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Experience with cell and gene therapy test methodologies (i.e. PCR, Flow Cytometry, cell-based assays). In this role, you will be responsible for executing testing cell and molecular biology assays, as well as basic laboratory maintenance in support of ElevateBio's gene and cell therapy programs.
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The postdoc in Gene Therapy vector engineering will participate in the development of novel AAV-based gene therapies and their process development. The primary role is to design and produce novel AAV material at various scales to advance gene therapy programs.
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Responsibilities We are seeking a highly motivated Vice President of Operations who will be responsible for the launch, ramp-up, and oversight of cGMP Operations within a state-of-the-art multi-product cell therapy manufacturing facility that will be utilized to manufacture autologous and allogeneic cell therapy products.
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PhD or equivalent and 4+ years of relevant experience; may include postdoc experience, Gene Therapy positions will require a PhD in Pharmacology, Neuroscience, Endocrinology, Physiology, or closely related discipline.
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quality assurance manager gene therapy jobs Title: manager operations
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