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PROTEIN SCIENTIST IRVINE, CA Project Description: Scientific leader responsible for development and validation of analytical methods for the characterization of proteins and peptides. Provides scientific leadership as an expert in various analytical and biophysical techniques including but not limited to chromatography, mass spectrometry, UV, fluorescence, light scattering, subvisible particle analysis, CD, AUC, DSC, and ITC. Contributes to the establishment of strategies for the development of analytical methods to monitor purity and stability of biopharmaceuticals and protein reagents. Contributes to the design and execution of experiments focused on biophysical characterization of proteins and peptides. Provides scientific expertise in establishing drug substance formulations. Additionally, the scientist is responsible for maintenance of analytical instruments. Position requires individual to work with Select Agents. Access to, and use of, select agents is covered by Federal policies. Violation of, or failing to support the intent of, Select Agent policies, regulations, or laws can result in substantial fines and/or imprisonment, as well as civil monetary penalties and are considered grounds for dismissal. Required Skills: Strong analytical and instrument skills and a thorough understanding and working knowledge of analytical and biophysical method development and validation with emphasis on biophysical methods. This experience is generally acquired through a combination of appropriate education (Ph.D.) and 0-4 years of applied experience. Individuals with a MS degree and 5 or more years of applied experience may also qualify. MUST possess a strong background in biophysical characterization of biologics. Must work with, and/or supervise staff handling potent neurotoxins and in-process samples that may contain toxin-expressing organisms. Excellent writing and communication skills. Skilled in the application of scientific design principles and analytical methodologies to the problems associated with biologicals and/or biopharmaceutical development. Extensive experience with a wide variety of biophysical methods for protein characterization (light scattering, CD, AUC, DSC, ITC, fluorescence, subvisible particle analysis, etc.) as well as related techniques such as HPLC and capillary electrophoresis. Excellent instrument skills including the use of the associated software. Experience with performing characterization work for regulatory submissions and/or the development of methods for application within a QC environment Leadership skills sufficient to motivate and develop a small group to ensure maximal productivity and quality results. A working knowledge of the requirements of working in a GLP or cGMP environment is helpful. This 12 month position starts ASAP. Please E-MAIL your resume (attachment to email) with rate and availability to Karen: ~~~ ALPHA'S REQUIREMENT #18-00822 W2 ONLY MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE