Biochemical Scientist
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Job Description
I. Position OverviewAssociate Scientist II is primarily responsible for testing samples, drafting methods and reporting data under cGMP regulatory guidance for Large Molecules/Biologics product development and related stability studies. In support of Large Molecules/Biologics Therapeutics, will execute laboratory testing using the following techniques as required: Compendial assays, (i.E., appearance. PH, Osmolality, Particulate measurements, Viscosity etc.) Karl Fischer UV-Vis HPLC/UPLC techniques/methods (e.G., SEC, IEX, RP-HPLC, HIC, peptide map, glycan analysis, etc.) Aggregation techniques such as MFI, AUC, SEC-MALS Capillary and Gel Electrophoresis (e.G., Client-SDS, SDS-PAGE, icIEF, IEF, western blot, etc.) FTIR, CD, Intrinsic Fluorescence, DSC Other technologies/methodologies as required by management
II. Essential FunctionsReads and follows Standard Operating procedures with attention to detailsSuccessfully trains on 1-2 methods and/or techniques mentioned above and performs adhoc sample testing activities under cGMP as requiredApplies basic scientific and laboratory concepts and theories related to specific testing in the groupFollow cGMP requirements for legible, accurate and thorough documentation to meetregulatory compliance. Supports drafting of simple methods, method forms and result reports.Adheres to policies, processes, and procedures for operating laboratory equipment in a safe and compliant mannerUnderstands the Client culture, programs, and communication processes regarding quality, safety, and ethical practicesAll other duties as assigned
III. Position RequirementsEducation and Experience:Bachelor s Degree in Life Sciences or Physical Science field. No work experience required
Knowledge/Skills Requirements:Has basic knowledge of the principles and concepts of a discipline (e.G., Biology, Chemistry, Biochemistry).Excellent written and verbal communications skills with internal customers, colleagues, and supervisorWell organized with ability to multitask and be flexible with daily work scheduleAbility to work effectively under pressure to meet deadlinesAbility to pay attention to detail and exhibit critical thinking
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