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By applying and developing NMR methodologies, the Scientist will work closely with analytical and organic chemists supporting chemical and biological processes to understand key aspects of synthetic products, manufacturing, and biologics.
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Company: Bionova Scientific LLC Job Description: Company Summary: Bionova is a rapidly growing, biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes.
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5+ years of hands-on Quality Systems experience working within a Cell and Gene Therapy or Biologics manufacturing environment. Collaborating with cross-functional groups including Manufacturing, Quality Control, IT, Engineering, and Validation to identify risks, develop mitigation strategies, and resolve issues, ensuring the smooth functioning of Quality systems including TrackWise QMS, Veeva and Labware.
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In addition, the QM Director will coordinate quality agreements with internal and external sponsors of cell therapy and biologics development and manufacturing for experimental clinical trials.
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Responsible for developing biologics process control strategy document, technology transfer change controls, engineering, clinical, and PPQ batch protocols in coordination with R&D and ensuring that the manufacturing batch record meets established conditions as defined in the CMC documentation.
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Medical Device - Wound Care Sales - Biologics. Medical Device Sales selling Biologics, Regenerative Medicine or Wound Care. Medical Device - Wound Care Sales - Biologics. Medical Device Sales selling Biologics, Regenerative Medicine or Wound Care.
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The Manufacturing Technician is responsible for supporting the overall GMP Fill Finish manufacturing processes, through the application of broad knowledge of theories, techniques, and principles utilized to solve operational and routine tasks in the aseptic production of finished drug product biologics for commercial GMP manufacturing.
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5+ years’ experience in GMP Quality or Manufacturing in biopharma/biologics/pharma industry. We are looking for a Manager/Senior Manager of Quality Operations to help provide quality oversight for our biologics commercial and clinical development programs.
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Previous experience in specialty biologics, pharmacy benefit reimbursement/access, specialty pharmacy, and/or Market Access a plus. Field Reimbursement Manager (FRM), Pulmonology and Gastroenterology - Albany, NY.
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Apply a fundamental understanding of Upstream (Cell Culture) bioprocessing to support biologics technology transfer, process validation, and plant start-up. In this vital role you will be a part of the Process Development Drug Substance Technology group at Amgens FleX Batch Biologics Manufacturing Facility.
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This role will provide strategic HR Business Partner leadership to support the local Biologics Operations Leadership Team, in their execution of the Global Product Development & Supply ("GPS") organization's People Strategy.
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Organization Janssen Biologics (7266) Apply Quality Systems: Event and CAPA Management System, Document Management System, Learning Management System, Change Control System and new technologies.
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The incumbent is responsible for tasks associated with the technology transfer for sterile drug products and Biologics. Knowledge and expertise in Biologics are preferred with experience in single-use system (SUS) technologies and compliant process segregation as an important core service August Bioservices provides to clients.
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Of cell therapy, high value biologics, and population-based public health research. of cell therapy, high value biologics, and population-based public health research. also participate in the assembly of kits and label printing.
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Experience with Preclinical to commercial product development and experience in biologics preferred. Critical thinker with a comprehensive understanding of biologics regulatory requirements, risk management principles, and science-based decision making.
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biologics job
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