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Interact regularly with multi-functional staff from Analytical Sciences & Quality Control, Drug Substance Process Development, Manufacturing Technical Services, Quality Assurance, and/or CMC Regulatory Affairs to support progress of the program and preparation of source documentation supporting BLA.
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Develop and optimize robustandscalable drug substance manufacturing processes (upstream and downstream) for GMP manufacturing of biologics for clinical and commercial supply. Scientist I is responsible for developing,characterizingand supporting technology transfer of robust drug substance manufacturing processes for biologics.
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Lead product and impurity characterization for Alexion’s drug substance and drug product. Establish phase-appropriate product degradation pathways for Alexion’s drug. Product Development and Clinical Supply team, leads Alexion’s efforts to support new molecule manufacturability assessments and characterization of its biotherapeutics by physical and chemical means.
ExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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This is what you will do: Scientist I is responsible for developing, characterizing and supporting technology transfer of robust drug substance manufacturing processes for biologics. The candidate is expected to a lead team, perform detailed scientific research, execute experiments, analyze experimental data, and provide recommendations to improve efficiency of drug substance manfuactuing.
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The Stability Associate II will work in collaboration with members of Analytical Sciences (AS), Biological Drug Substance Development (BDSD), Injectable Drug Product Development (IDPD), Device Development (DD), Quality Assurance (QA), and other members of Product Development and Clinical Supply (PDCS) as well as external vendors as required.
Full-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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This position is expected to interact regularly with cross-functional staff from Analytical Sciences & Quality Control, Drug Substance Process Development, Manufacturing Technical Services, Quality Assurance, and/or CMC Regulatory Affairs to support progress of the program and preparation of source documentation supporting BLA.
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Bachelor’s degree with previous experience in an appropriate scientific discipline (Biochemistry, Biomedical Engineering, Chemical Engineering or related discipline consisting of a combination of appropriate education, training and/or directly related experience.
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Responsible for all aspects of on-site stability sample storage and sample management. Previous experience with SAS JMP or other statistical software preferred. Previous experience with Laboratory Information Systems (LIMS) preferred.
ExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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Knowledge of Lean Six Sigma preferred. Able to navigate external vendor sites and portals for data extraction and review, as needed. Author stability Protocols, Reports, SOPs and Quality documents as required.
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In an appropriate scientific discipline (Biochemistry, Biomedical Engineering, Chemical Engineering or related discipline consisting of a combination of appropriate education, training and/or directly related experience.
Full-timeExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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Collaborate effectively with various teams, including but not limited to Analytical Sciences, Biological Drug Substance Development, Injectable Drug Product Development, and Device Development.
Full-timeExpandApply NowActive JobUpdated 3 days ago
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