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Plan and execute small-scale process development experiments and develop viable cGMP manufacturing processes for cell culture and cryopreservation. Experience in aseptic handling of cell cultures with preference for stem cell culture maintenance and differentiation.
$75,000 - $95,000 a yearFull-timeExpandUpdated 5 days ago - UpvoteDownvoteShare Job
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How to apply your experience in bioprocess & cell culture to the production of next-generation seafood utilizing cGMP practices. How to apply your experience in bioprocess & cell culture to the production of next-generation seafood utilizing cGMP practices.
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Technical knowledge of manufacturing systems, methods and procedures, biopharmaceutical manufacturing processes, knowledge of regulatory aspects (cGMP). Subject matter expert relative to manufacturing and MES Master Batch Records.
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With 180+ staff, they provide programming, master planning, building, and interior design services, including laboratory, cGMP, and medical planning, to new and established companies, institutions, developers, and healthcare providers.
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Possess a strong knowledge of the FDA, cGMP, and GCP standards as well as regulatory guidance documents such as Annex 13. Possess clinical supplies experience/knowledge in forecasting, demand / supply planning, IRT systems, inventory management, clinical labeling and distribution including cold chain, import/export, and reverse logistics.
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Proven understanding of cGMP antibody upstream process development and production using CHO host cell expression systems at bench or pilot scale. The Upstream Process Development team is responsible for the development and implementation of upstream processing methodologies on monoclonal antibodies that can be efficiently transferred to the cGMP Manufacturing Team and our CDMO partners.
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