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B.S. degree in food, chemistry, microbiology, biology or related is required. Prior QA/QC experience in food manufacturing is a plus. Conduct a specific micro testing under guidance of the microbiologist.
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RedShiftBio Ⓡ is a forward-thinking technology company that aims to reimagine and reengineer analytical tools in life science research and biopharmaceutical drug development, tackling previously unsolvable problems in structural biology and bioprocessing.
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Demonstrated experience in cell and molecular biology techniques (e.g., cell-based assays, flow cytometry, qPCR, ELISA, and aseptic technique). The Scientist, QC Analytical (Flow Cytometry) at the Cell Therapy Facility (CTF) is responsible for performing as a subject matter expert in the completion of QC bioanalytical testing or data review for method validation, critical reagent qualification, in-process, release, and stability testing of clinical and commercial cell therapy drug product.
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In depth knowledge of common analytical techniques used in the bio-pharmaceutical industry such as iCIEF, UPLC, CE, Bioassay, ELISA, LC-MS etc., including method qualification/validation, method development and/or method transfer.
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Hands-on experience with various bioanalytical techniques including ELISA, qPCR and FACS. Hands-on experience with various bioanalytical techniques including ELISA, qPCR and FACS. The QC Analyst is responsible for supporting Quality Control analytical testing of Incoming Raw Materials.
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Some of the testing methods performed in-house are HPLC/UPLC, conductivity, OSMO, titration, melting point, and various other techniques. Support document revision, project, CAPA, and investigation/deviation-related tasks.
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Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements. Review all data in accordance with applicable procedures and cGMP requirements. Document training per procedural and cGMP requirements.
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