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Establishes and executes development project plans (e.g., process and assay development, assay qualification, support tech transfer of processes) from cGMP manufacturing and assays to quality control.
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Lead right-first-time cGMP manufacturing of cell and gene therapy products including but not limited to aseptic processing, cell isolation, selection, culturing, cryopreservation, upstream processing, downstream processing, aseptic fill finish and final product visual inspection.
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You'll collaborate closely with our Process Liquids Solutions Technical Sales Executives (TSEs) to identify and cultivate opportunities for custom cGMP process liquids manufacturing services, aimed at simplifying bioprocess workflows both upstream and downstream.
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JOINN Biologics is a contract manufacturing service company, located in San Francisco Bay Area with professional team and cGMP facility in JOINN Innovation Park. JOINN Biologics offers process development, including cell line development and cell culture, upstream process development, downstream process development, analytical services.
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The ElevateBio ecosystem combines multiple R&D technology platforms – including Life Edit, a next-generation, full-spectrum gene editing platform; comprehensive cell engineering technologies; and an expanded viral and non-viral therapeutic delivery platform – with BaseCamp®, its end-to-end genetic medicine cGMP manufacturing and process development business, to accelerate the discovery and development of advanced therapeutics.
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The company focuses on producing cell culture products, instruments, and solutions that help customers streamline their discovery, development, and production processes, and by making custom cGMP bioprocess liquids that radically simplify customers' manufacturing workflows - regardless of batch size.
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Biopharmaceutical Development and Manufacturing Services Beyond supplying high quality proprietary APIs, we provide contract process development & cGMP manufacturing services, including heparin derivatives, natural products extraction, fermentation and purification.
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AGC Biologics (AGC) is a global Contract Development Manufacturing Organization (CDMO) with bio-manufacturing facilities in Europe, Japan, Italy and the USA. The company provides a comprehensive range of commercial and clinical cGMP biologics manufacturing services, from DNA to active pharmaceutical ingredient (API.
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Independently provide complex technical support of cGMP manufacturing including authoring of complex technology transfer documents, change controls, manufacturing impact assessments, and study protocols.
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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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The Manufacturing Specialist Lead role will be responsible for ensuring successful manufacture and release of cell therapy products following all processes and procedures related to operations in full compliance with cGMP. This role will be leading the manufacturing operational readiness and successful tech transfer using knowledge of cGMP regulations.
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Follow Good Documentation Practices (GDP) to complete all documentation required for batch processing in a cGMP compliant manner, including master manufacturing records (MMR), process labels, room and equipment logbooks, and in-process documentation.
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Strong understanding of regulatory requirements and guidelines for cell and gene therapy manufacturing (e.g., cGMP, FDA regulations). About AMEC New Albany, OH: AmplifyBio’s Manufacturing Enablement Center provides customizable cGMP suites to enable advanced therapy manufacturing in a “hoteling model,” traditional contract development and manufacturing (CDMO) or a hybrid model.
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Maintain records to comply with regulatory requirements utilizing current Good Manufacturing Practices (cGMP) and SOPs. AA or BA/BS in a technical field (biotechnology, chemical engineering, bioengineering, microbiology, biochemistry) or equivalent experience, and experience working in a cGMP industrial setting.
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The Associate Scientist - QC Manufacturing performs and directs assays according to and in compliance with Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP), Code of Federal Regulations (CFR) and/or Points to Consider (PTC) guidelines and Standard Operating Procedures (SOPs.
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