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The incumbent in this role will support entry, junior, and experienced level professionals at the Libertyville Vector Manufacturing Facility (VMF), tasked with performing on demand, and. Minimum 7 years’ experience working directly with manufacturing and laboratory equipment (e.g., CTUs & CRTs, upstream and downstream equipment, Filler Machine, analytical lab equipment, autoclave, AKTA, etc.
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Set up, calibration, and operation of Phase Network Analyzer (PNA) or Vector Network Analyzer (VNA) This position requires Phase Network Analyzer (PNA) or Vector Network Analyze (VNA) experience, as well as RF tuning skill to the device level.
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This 6-month position centers on drug substance process development for gene therapy but will interface with a broader team of vector and cell line engineering, upstream process development, analytics, and clinical manufacturing support.
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About the role:The Laboratory Technician, Pre-Clinical Vector Manufacturing reporting to the Vector Manufacturing Team Lead is responsible for supporting routine laboratory operations related to manufacturing research-grade recombinant Adeno-associated virus (rAAV) vectors as part ofVector Core. The rAAV vectors manufactured support capsid technology development, intellectual property portfolio and progression of internal and external early-stage gene therapy programs.
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GenScript's businesses encompass four major categories based on its leading gene synthesis technology, including operation as a Life Science CRO, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy.
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In terms of viral vector service, GenScript ProBio has a stable and high-yield viral vector platform. GenScript ProBio's total cell and gene therapy solution covers CMC of plasmid and virus for IND filing as well as clinical manufacturing and commercial manufacturing.
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It is also the first GMP manufacturing platform to provide in vitro transcription (IVT) template linearized plasmids for mRNA vaccines and has supported several mRNA vaccine global enterprises to obtain clinical approvals.
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Work closely with Global Product Quality, External Manufacturing, and Supply Chain to understand forecasts and deadlines to ensure timely CoA/CoT (Certificate of Analysis/Certificate of Testing) generation for Cell Therapy vector products.
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By merging innovations in AI and RNA technology to generate and analyze hundreds of billions of therapeutic possibilities, ShapeTX is developing breakthroughs in RNA editing, next-generation AAVs, and disruptive gene therapy manufacturing.
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Experience with Analytical Methods and/or Laboratory operations related to Viral Vector Manufacturing is preferred. Partner cross functionally with Global Product Quality (GPQ), External Manufacturing (ExM), Manufacturing Science & Technology (MS&T), Analytical Science & Technology (AS&T), Supply Chain (SC), and teams within Vector External Manufacturing Quality to support activities related to release of commercial vector in a timely manner.
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This role may also partner cross functionally with Global Product Quality (GPQ), External Manufacturing (ExM), Manufacturing Science & Technology (MS&T), Analytical Science & Technology (AS&T), Supply Chain (SC), and teams within Vector External Manufacturing Quality to support activities related to release of commercial vector in a timely manner.
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Products within the S&M subsystem that you will support include vehicle primary and secondary structures, landing and launch vehicle separation mechanisms, crew and cargo support mechanisms, and thrust vector control.
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This includes, but is not limited to, raw materials, vector, supplier quality, audits and inspections, training, quality systems, quality operations, quality control, contract testing labs, and contract manufacturing organizations.
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Based on our innovative approach to developing genetic medicines, as well as our industry-leading internal manufacturing capability and expertise, we have become the Astellas Center of Excellence for their newly created Genetic Regulation Focus Area. We are currently exploring three gene therapy modalities: gene replacement, exon skipping gene therapy, and vectorized RNA knockdown, with plans to expand our focus and geographic reach under Astellas.
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The Analyst II, QC will be responsible for implementing and executing analytical testing in support of clinical and commercial viral vector products in compliance with GMP requirements. This is an on-site role working in a cGMP regulated manufacturing facility.
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