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Downstream biologics process development technology transfer, scale-up and ongoing manufacturing of biologics (cGMP) including technical support for nonconformance investigations and other commercial support activities.
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The primary focus of the position will involve general lab support and downstream process development of recombinant proteins. Icosavax seeks a Research Associate II with a background in general lab operations and downstream process development to advance our clinical manufacturing programs.
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We are seeking a Downstream Technician II responsible for expanding our lab-scale recovery capabilities to remove or recover micro-organisms and bioactives from broth generated at our Fermentation Research Facility in Wilmington, DE.
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The successful candidate will work closely with members of the pilot plant and process development teams who are responsible for fermentation and downstream processing. The Pilot Plant team is seeking a BioProcess Development Associate 2 to support the development and pilot-scale production efforts in our pilot plant.
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Transfers and Introduces technology of cell therapy-based and therapeutic protein processes into manufacturing collaborating extensively with Scorpion’s Process Development group to develop cGMP-compliant, clinical-scale production processes.
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May support various experiment preparation and execution as directed to include, but not limited to; execution of cell culture, harvest and downstream purification process studies using 500 L scale pilot equipment including bioreactors, chromatography skids and filtration systems.
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Experience with cell and gene therapy tech transfer, scale-up, validation, and commercialization. Lead the tech transfer, development, and optimization of manufacturing processes for advanced therapies, including cell culture, gene editing, downstream processing, fill/finish operations.
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Experience in upstream and downstream process development scale-up. Demonstrated experience with protein, DNA, or viral purification by standard chromatography methods as well as fluency with the theoretical concepts underlying protein purification.
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The role report to NPI Lead for site MSAT and will be responsible to support all aspects of upstream and downstream processing for multiple clinical-scale cGMP manufacturing trains employing the innovative Just-Evotec continuous processing platform in 24/7 operations.
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These functions may include but are not limited to activities such as propagation of mammalian cell culture, conducting aseptic cell culture operations, execution of large scare production bioreactors (50L - 2000L), conducting large scale chromatography, viral inactivation, viral filtration, ultrafiltration and diafiltration, as well as aseptic filling of bulk drug substance.
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Must have at least 3 years of post-bachelor working experience in a Biotech, Pharma, or Academic lab with hands-on experience in protein purification using lab scale AKTA instruments, UNICORN software, and chromatographic resins.
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Manufacturing cGMP production activities include solution preparation, master/working cell bank production, upstream cell culture, downstream protein purification, mRNA and molecular therapeutics production, and small-scale fill/finish.
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Since its founding in 2016, Galehead has deployed its proprietary LandCommand® technology and specialized upstream platform to develop more than 15 GW of solar, storage, and wind projects under active development by Galehead and its Downstream Partners including Tyr Energy Development, EDF, Clearway, Rev Renewables, Steelhead, Engie, and Longroad.
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Downstream analysis will include analysis of the relationship between variant functions and interactions with protein or RNA structure, and with yeast or human phenotypes. The role will also require the demonstrated ability to both use and develop experimental and computational tools for the support and analysis of large scale mutagenesis, sequencing-based multiplexed readout of variant functional or interaction assays, and dissemination and analysis of the resulting maps.
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As our Process Engineer, you will primarily be a Subject Matter Expert SME for large-scale downstream manufacturing processes. This position is a great opportunity for someone with various levels of experience to enter a MSAT role focusing on the Downstream Purification portion of a manufacturing process or a recent graduate with a strong chemical engineering background where chromatography and filtration was a focus.
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