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Under the direction of the Engineering Department and the Maintenance Planner, the Maintenance Technician will support the maintenance needs, both mechanical and electrical, of Operations and Production in standard conditions, including troubleshooting and repair, preventative and predictive maintenance.
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1-5 years experience in viral vector/cell therapy (or biopharmaceutical) based GMP manufacturing operations including direct experience in cell culture, cell selection, recovery, purification, and/or aseptic fill/finish.
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The role oversees and manages the Development QA team and interacts cross-functionally with functional teams who interact with and/or support Preclinical and Clinical Trials, which include Preclinical and Clinical Operations; and, Product Development, GMP teams, Pharmacovigilance, Medical Writing, Biostatistics and Data Management to ensures compliance to the Quality Management System (QMS) and all applicable regulatory requirements.
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Role, you will use existing SOPs and quality assurance standards to monitor, observe, and record animal health and welfare daily, as well as complete various standard animal husbandry duties. can streamline research by delivering operational and cost efficiencies through the strategic insourcing of GMP, GLP and non-GLP research services from discovery through safety assessment.
$20 - $22 an hourExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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We are establishing commercial processes that require a solid practical foundation in standard bioprocess unit operations ( e.g. UF/DF, normal flow filtration, mixing systems, chromatography). Our team looks forward to welcoming an experienced Bioprocess Engineer with a strong background in the regulated (bio)pharmaceutical environment supporting laboratory, pilot and commercial scale process development, mRNA technology transfer to internal and external GMP production facilities and commercial production of mRNA therapies.
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Operating in standard seasonal warehouse and food processing plant temperature conditions will be required. Position will also frequent the production floor, so operating in standard seasonal warehouse and food processing plant temperature conditions will be required.
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The Hoddesdon site has state-of-the-art Good Manufacturing Practice (GMP) standard facilities for the development of Active Pharmaceutical Ingredients (API), Formulation Development (FD) and Process Chemistry (PC.
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Adhere to standard operating procedures, laboratory methods and protocols under GLP/GMP-like conditions for the production and analysis of a tissue engineered product. Familiarity with appropriate word processing, spreadsheet, presentation and related standard software.
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The Scientist, Analytical Development will be required to assist QC/QA in investigations as an SME. All duties will be performed in compliance with company standard operating procedures (SOPs) and GMP (Good Manufacturing Practices) regulations, as appropriate.
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AGC Biologics A/S is a global CDMO, where we work with the development of biopharmaceutical manufacturing processes and GMP manufacturing of biopharmaceutical proteins for both clinical testing and marketing.
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Summary: We look forward to welcoming a Bioprocess Engineer with a solid understanding of bio-chemical engineering fundamentals and modeling expertise to support our laboratory, pilot and clinical scale process development, technology transfer to internal and external GMP production facilities for our novel cell free expression-based therapies.
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Establish and maintain analytical assay performance trending program and reference standard trending program. Build GMP quality systems and the compliance infrastructure for the Quality Control labs.
Full-timeExpandApply NowActive JobUpdated 18 days ago - UpvoteDownvoteShare Job
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The QC Chemist I will be responsible for performing various analytical techniques and common standard lab practices in order to assess the quality of pharmaceutical products under cGMPs (as applicable) and limited supervision.
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The Associate Director, QC Cell Culture and Bioassay will be responsible for overseeing a testing laboratory charged with the execution of all GMP bioassay testing (release and stability) related to Sarepta' s Gene Therapy pipeline.
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In addition to performing the above testing, the incumbent will collaborate as a subject matter expert in Quality Control, Flow Cytometry and Clinical Diagnostic testing, as well as safety testing for the Good Manufacturing Practice Facility (GMP) and clients of the GMP, the Alpha Stem Cell Clinic, the CAR-T Manufacturing Program within the Stem Cell Program and Gene Therapy Center, and multiple University of California Researchers as well as private companies.
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