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Following established procedures according to Good Manufacturing Practices (GMP). Validating processes and equipment related to filtration, cleaning, and sterilization. Providing training support and assistance to lead/supervisor.
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Maintains accurate records and logs in accordance with FDA (Food Drug Administration) and GMP (Good Manufacturing Practice) Demostrate the ability to follow established procedures according to GMP (Good manufacturing Practices.
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Specifically, we are interested in new gene discovery, establishing in vitro and in vivo models, and designing new approaches for possible therapies. Specifically, the applicant should have experience and skills in Western assay, polymerase chain reaction (PCR), recombinant DNA manipulation, CRISPR, cell transfection, cell culture, immunohistochemistry, and fluorescence microscopy.
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Experience within cell and gene therapy strongly preferred. Help build the mRNA and Cell Therapy sales process and record information in Salesforce (SFDC) database to enable both peers and commercial leadership across the greater Thermo Fisher network to communicate and succeed.
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Performs laboratory work and documentation in accordance with GMP, GLP and company guidelines. Understanding of the GMP and GLP laboratory guidelines. Basic understanding of chromatography theory and hands-on experience with HPLC.
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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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OVERVIEW The Sr. Control Engineer is responsible for maintaining instrumentation and control systems in support of plant production, quality, GMP and safety goals. ESSENTIAL CAPABILITIES (KNOWLEDGE, SKILLS, ABILITIES AND PERSONAL ATTRIBUTES) Demonstrated knowledge of one or more of the following: Wonderware System Platform & InTouch, Allen Bradley PLC systems (PLC5, SLC500, and ControlLogix) and associated I/O systems, Allen Bradley VFDs / Soft Starters / Servos, Allen Bradley Centerline MCCs, process instrumentation (analog valves & transmitters.
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Preferred knowledge of the following industry regulations FDA (Food and Drug Administration), GMP (Good Manufacturing Practice) / QSR (Quality System Regulation), ISO (International Organization of Standardization.
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We're seeking an experienced Team Leader to head our batch record review team at the Cell & Gene Manufacturing facility in Maryland. Experience in Cell & Gene Therapy. Oversee the review of batch records for completeness and compliance with SOPs, GMP guidelines, and regulatory requirements.
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5 years of applied Microbiology experience in a commercial pharmaceutical, GMP manufacturing environment (preferably parenteral and in a CMO/CDMO/Clinical Environment) The Microbiology Manager provides oversight of activities related to microbiological testing of bulk and finished products, packaging materials, scale-up samples, process validation samples, marketed stability samples, development, and investigational samples.
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Work with R&D and tech transfer team for successful transfer of Programs into the GMP area. Ensure slow and purposeful movements appropriate for a Grade A/B GMP aseptic environment. Work with R&D and tech transfer team for successful transfer of Programs into the GMP area.
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The Transportation Manager plays a pivotal role in overseeing all aspects of Transportation Operations for the plant, ensuring strict compliance with DOT, environmental, and GMP policies and procedures.
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Well-versed in digital media management utilizing GMP, yielding results for clients’ investments, i.e. sales/lead conversion and omni-channel acquisition. Reporting directly to VP Tech & Analytics, as the Director of GMP Solutions you will be responsible for various aspects of our GMP division, including supporting sales, fostering relationships with the Google GMP team, and leading a team of consultants dedicated to client relationship management and business growth.
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The Cell Therapy Specialist will perform and/or verify all tasks associated with the manufacture of commercial product following batch records and standard operating procedures (SOPs) to ensure safe and compliant operations as well as works as part of a team to execute GMP runs in close collaboration with Materials Management, Quality Control and Quality Assurance.
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They will also generate mutants using CRISPR and analyze changes in gene expression. This individual will set up and perform experiments studying gene regulation in the fly retina. Previous experience with molecular biology, fly genetics, cell culture and/or DNA/protein molecular biology software is strongly preferred.
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