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Support the development of a new purification process by reviewing and compiling relevant literature data. We are seeking a Scientist to join our Downstream Process Development Department - Process Sciences in Gaithersburg, MD. Qualified individuals will play a role in downstream process development; scale up, new technologies, and technical support of cGMP manufacturing for protein particle vaccines.
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Solid working knowledge of various manufacturing platforms (Microbial fermentation process, IB recovery and refolding, CHO cell culture and purification, Pegylation, PEGylated protein purification etc.
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Join our Process Development Team in using a variety of fermentation techniques, purification techniques, and characterization methods to support commercial and bench scale pharmaceutical processes.
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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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Process development and manufacturing experience includes mammalian and/or microbial cell culture and scale up, the isolation and purification of proteins, antibodies, etc., extensive experience with product recovery (depth filtration, centrifugation, MF), TFF (UF/DF), chromatography (Affinity, IonX, HPT, HIC.
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We are currently seeking a highly motivated and experienced Senior Scientist to join our Downstream Process Development group. Senior Scientist - Downstream Process Development.
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Executes Design of Experiments (DOE) and Proven Acceptable Range (PAR) experiments to support design space understanding and process validation as they relate to oligonucleotide synthesis, process chromatography, and other purification and isolation techniques.
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Provide support for execution of process development activities and manufacturing investigations. This position will report to the Technical Operations Department and will support the manufacture of HPV Gardasil as part of a multidisciplinary team, the candidate will have a fundamental knowledge of fermentation and cell culture, protein chemistry and purification, analytical techniques and/or laboratory operations.
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The Senior Scientist I will play a key role in the developing downstream purification process development for various modalities such as mAbs, ADCs, bio-specifics, gene therapy, etc.
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They will also be a member of the Pivotal/Commercial Biologics Technical Development Leadership Team, that is responsible for providing leadership and decisions on the development and commercialization strategies for all aspects of late-stage process development (Cell Culture, Purification, Drug Product, Analytical Sciences, MSAT, and Materials Sciences.
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On experience in cell-culture process development. Drive development and implementation of new process technologies to meet business and portfolio needs. Partner with cross functional members across Gilead Pharmaceutical Development & Manufacturing (PDM), including Quality, Supply Chain, Manufacturing, Regulatory Affairs CMC, Finance and Technical Development to ensure successful commercialization of the late-stage portfolio, as well as on time delivery of clinical and commercial product.
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Process development and product development for new vape, concentrate, and infused products. Conduct extraction process development work from bench top pilot projects through production scale batches, via experimental design and process validation.
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Documents analyses by completing experiment notebooks and records; implementing process chemistry applications and analyzing results of new oligonucleotide synthesis and purification methods and processes.
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Analyze polysaccharides with analytical methods including but not limited to colorimetric assays, HPLC assays, and SEC-MALS. Determine and elucidate the process required to ensure consistent, robust, large-scale polysaccharide purification processes suitable for manufacturing production.
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Performs purification and analysis of samples for upstream process development activities, including but not limit to POROS titer assay and spent media amino acid analysis. Performs early-stage upstream process development of mammalian cultures for production of recombinant therapeutic proteins.
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