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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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Familiar knowledge of GLP and GMP requirements as they pertain to protein and gene therapy process development and Quality Control (QC) testing is a plus. Leads the laboratory-based analysis of the physico-chemical and biological properties of proteins and gene therapy vectors and establishes the laboratory standards to determine identity, strength, purity, potency and quality for research and development candidates.
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Reporting to the Executive Director of Analytical Development and Quality, the Director of Quality Control provides leadership of a scientific team that will execute the development and management of analytical assays related to AAV-based gene therapy programs.
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As part of a cross-functional team which includes the GTP Vector Program's MS&T and AS&T teams as well as GTP's GMP Quality Assurance (QA) group, the External Manufacturing team will support internal and external manufacturing activities to deliver high-quality viral vectors for gene therapy research, clinical trials and commercial products.
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Basic understanding of viral vector-based gene therapy processes, principles, and quality requirements. 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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American Society for Quality (ASQ) Certified Manager of Quality and Organizational Excellence, ASQ Quality Engineer, or ASQ Quality Auditor certifications. Five years of experience working in a Quality Control, Quality Assurance group as an inspector, or in non-destructive testing.
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The Quality Assurance Manager leads the plant operations team in assessing all matters pertaining to product quality, food safety, and regulatory compliance as the senior technical leader at the production facility.
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Job DescriptionGeneral Summary:The Sr. Manager, Manufacturing Technical Operations (MTO) is responsible for managing compliance related Quality records including, but not limited to, Deviations, CAPA’s, Change Controls, Risk Assessments and Analytical and Quality Control Investigations supporting Biopharma Cell and Gene Therapy (CGT) in Boston, Cambridge, and Providence.
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In support of these efforts, we are seeking a hard-working Manager, Quality Control- Microbiology who is serious about their discipline and wants to be a key player in a high-performing team.
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This role serves as Quality Assurance Manager for the Cedar Creek site, that manufactures and distributes products for multiple divisions in the Diagnostics and Genomics Group. Responsibilities includes but are not limited to quality operations, supplier quality, quality engineering, field actions, product investigations, document control, change control, training, non-conformances, deviations, CAPA, management review, audits, inspections, complaint investigations and post market surveillance.
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Conduct nonclinical development activities (pharmacology and toxicology) for IND-enablement of gene therapy products. Maintain current understanding of gene therapy field, as well as the scientific literature related to specific drug discovery projects.
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Reporting to the Director, Technical Writing, CMC Regulatory, CARGO is hiring a Senior Manager, Technical Writing to join the Technical (CMC) Regulatory writing function to help progress our cell-based gene therapy portfolio.
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As Gene Therapy Manufacturing Supervisor, 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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20+ years in the healthcare industry, including 5+ years in rare disease and/or gene therapy. The Associate VP Commercial, Gene Therapy and Gene Editing will serve as the go-to-market lead for Lilly’s one-time genetic medicines portfolio, responsible for developing and implementing strategic and operational commercialization plans.
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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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quality assurance manager gene therapy jobs Title: quality manager operations
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