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This role will provide QA oversight of the quality control bioassay and flow cytometry laboratories along with raw material, analytical development, and supply chain groups in support of Vertex Clinical Cell and Gene Therapy Programs.
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Committed to adherence to regulatory standards, this team performs comprehensive testing on AAV gene therapy products, evaluating vector potency, identity, purity, and stability. Experience with the analytical methods used for gene therapy in-process testing, release testing and characterization, with an emphasis on LC-MS, LC-MS/MS and HPLC.
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Experience working in the fields of gene therapy, cell therapy, or another emerging therapeutic technology is highly desired. Adverum is a clinical-stage gene therapy company targeting unmet medical needs in ophthalmology and rare diseases.
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Discovery Life Sciences (Discovery) is a leading provider of highly characterized human biospecimens and cellular starting materials to advance cell and gene therapy and precision medicine programs for cancer, infectious disease, and other complex conditions.
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About HemaCare HemaCare, a Charles River company, is a global leader and trusted brand in the customization of human-derived biological products and services for biomedical research, drug discovery, and cell and gene therapy development.
$39.86 - $49.23ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Responsibilities -Develop assays for GMP release of gene therapy products-Develop assays for product characterization of gene therapy products-Develop assays for AAV/protein/DNA to assist in evaluation of process change, formulation andstability study-Report project status (development plans, timelines, and results) to supervisor and technical teams.
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Experience managing GMP related EPCMV projects ($5M+) within a Cell/Gene Therapy or Pharmaceutical Manufacturing Environment is required. At Bristol Myers Squibb we are reimagining the future of cell therapy.
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Essential Duties and Responsibilities include, but are not limited to, the following:Individual Contributor responsible to execute QA Validation Strategy for clinical and pre-commercial cell and gene therapy manufacturing facility.
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About Charles River Cell Solutions Charles River Cell Solutions is a global leader and trusted brand in the customization of human-derived biological products and services for biomedical research, drug discovery, and cell and gene therapy development.
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Additionally, this role is part of the consolidated analytical development team within the Pharma Technical Cell and Gene Therapy (PTC) organization dedicated to advancing therapies aimed at treating or curing various diseases.
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Partnering with AmplifyBio for manufacturing cell therapy, gene therapy, mRNA, plasmid, or other modality is quite different from a typical CDMO experience. - Highly experienced and knowledgeable biological science laboratory professional with in-depth knowledge of HPLC and/or LC-MS for GMP use, including assay qualification/validation, technology transfer, and troubleshooting.
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This role requires a combination of CMC technical expertise (e.g. gene therapy, RNA, gene editing), effective communication, business and strategic acumen. Proclinical is seeking a Senior Director of CMC Technical Innovation to focus on Gene Therapy.
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Familiarity with gene therapy or rare disease therapeutics development process including patient selection for clinical trials. In this role, the Associate Director Companion Diagnostics will serve as the Companion Diagnostic (CDx) subject matter expert responsible for driving CDx development programs required for patient selection strategies for Spark’s gene therapy development teams, ensuring that the CDx deliverables align with the gene therapy development program milestones at critical junctures.
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Preferred Education, Skills, and Knowledge Experience with cell and/or gene therapy products is a plusELISA, Flow Cytometry, cell counting and viability assessment, etc. Support GMP investigations for out of specification test results and corrective actions Support problem solving for technical issues pertaining to GMP quality control, working alongside technical SMEs as needed.
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We are immediately hiring for a Quality Control Scientist II in the Gene Therapy field! Job DescriptionThis role will primarily perform a variety of documentation related work for the lab, with a focus on supporting materials release processes for gene therapy products that are used in clinical trials.
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