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The Research Associate is expected to work closely with the Upstream Process Development, Downstream Process Development, Analytical Development and Vector Core groups to foster a collaborative environment delivering sound and robust manufacturing processes for AAV vectors.
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10+ years Downstream Process Development experience related to biochemical engineering and/or protein biochemistry, scale-up principles, and manufacturing of Biopharmaceuticals (cGMP.
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Bachelor's degree and 15 years of Downstream Process Development experience. Master's degree and 10 years of Downstream Process Development experience. The candidate is expected to work hands-on while providing strong technical leadership and partnering with manufacturing, quality, supply chain, equipment engineering, research and development, and process scientists to produce clinical supply and work toward commercial facility licensure.
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This includes communication with Quality Assurance, Quality Control, Upstream and Downstream Process Development, Drug Product Development, Analytical Sciences and Supply Chain teams to ensure efficient tech transfer of Alexion's clinical drug substance manufacturing activities.
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BPR&D includes three lab-facing technical functional areas: Process Cell Sciences (PCS), Upstream and Downstream Process Development & Engineering. Beyond process development for pipeline biologics, we innovate and build next generation biomanufacturing technologies.
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Direct upstream or downstream monoclonal antibody process development, pilot production lab, or cGMP manufacturing experience. Vir Biotechnology seeks a contract Senior Research Associate with experience in upstream or downstream monoclonal antibody manufacturing or process development.
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Novavax is seeking a Senior Scientist to join our Downstream Process Development group in Gaithersburg, MD. Qualified individuals will play a leading role in downstream process development and process characterization activities, new technology evaluation, and technical support of cGMP manufacturing for proteins, nanoparticles, and virus-like particle (VLP) based vaccines.
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The downstream process development intern position is intended to provide an overview and instruction of the downstream purification process with a focus on viral reduction filtration in a biopharmaceutical/biotechnology industry setting.
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As a Process Development Scientist II, you will help our clients to deliver lifesaving and life changing therapies to patients in need. Knowledge of gene therapy product and/or process development preferred.
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As a Purification Research Associate II, you will be part of the Development Team and will work closely with members from Downstream, Analytical, and Upstream Process Development.
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Prior experience in relevant area to own domain (e.g., upstream/downstream cGMP experience, process development, HPLC/biological assays) strongly preferred. Minimum Requirement: Bachelor's degree with 7+ years experience in relevant scientific area (e.g., GMP: chemistry, biology, chemical engineering, analytical chemistry, biotechnology; ECTL: cellular biology, molecular biology, immunology, biochemistry.
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Cross-train on and provide support for upstream and downstream process development operations. Support viral vector process development and production by designing and performing fast and robust assays for the characterization of AAV.
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The latter two together form our Biologics’ Process Development (BPD) group. Biologics Process Research & Development (BPR&D) within our Research Laboratories is on a mission to rapidly deliver diverse biotherapeutics to patients by efficiently developing innovative, robust manufacturing processes and technologies.
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Evaluating and introducing novel technologies and analytical tools in process development and manufacturing. Knowledge of Quality by Design, Process Characterization and Control Strategy development.
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The Upstream Process Development Scientist conducts upstream process optimization, purification of biomolecules, and further processing to establish end-to-end bio-manufacturing. Degree in Chemical/Biochemical Engineering, Biotechnology, Genetic Engineering, Chemistry, Molecular Biology, Biochemistry, Microbiology, or a relevant field.
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