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The Role: The Senior Scientist, QC Microbiology will perform assay development, characterization, optimization, transfer, qualification, verification, validation and investigation for QC Microbiology group.
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The ideal candidate will have hands-on experience working with mammalian cell culture, protein expression, purification and analytical QC using diverse biochemical methods such as ELISA, SDS-PAGE, Western blotting.
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QC our in-house produced RNA and LNP formulation by in vitro testing. Perform a variety of in vitro and ex vivo assays, including but not limited to ELISA, qPCR, western blotting, enzymatic assay, immunohistochemistry, and immunofluorescence staining.
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Conduct Quality Control (QC) review of Bioanalytical data (LC-MS/MS, ELISA, qPCR, etc.) This position will report to the Sr. Manager, QC and Sample Management. Perform QC review of packing slips, sample manifests, and critical reagent documentation.
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Perform routine QC review of Electronic Lab Notebooks (ELN) to ensure adherence to guidelines. Working knowledge of bioanalytical assays (LCMS/MS, immunoassays, etc.) In this role, you will be responsible for the quality control review of scientific documents within the Translational DMPK and Clinical Pharmacology group.
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Design and develop data capturing tools: Electronic Data Capture (EDC) Systems (Eg: iMedidata Rave and IBM Clinical) eCOA, IRT; Manage electronic Trial Master File (eTMF) QC review eg: Veeva Vault; Lead the Audit and Inspection/Submission Readiness activities like documentation of QC and preparing Storyboards (Eg: FDA/EMA Submissions.
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This is what you will do: As a Senior Scientist at AstraZeneca in the Rare Disease, Genomic Medicine Department, you will be a key player in advancing gene therapy research, focusing on AAV (Adeno-Associated Virus) vector design and establishing a plasmid QC and tracking system.
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The candidate will be expected to troubleshoot and maintain automated workflows and platforms to support NGS/Immunology protocols, such as RNA and DNA isolation from tissue, cell free DNA isolation from plasma, library preparation, QC and other manual lab processes.
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The Director of QC Stability is responsible for maintaining and continuously improving our stability program to support our AAV gene therapy products. The Director of QC Stability will lead a team of 3-4 scientists and interact with multiple groups in the QC lab, CMC, Analytical Development, Quality, IT, and Manufacturing.
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Vor Bio is seeking an experienced Quality Control Senior Analyst to be a part of the team responsible for the day-to-day operations assigned to the QC Microbiology group, including sampling of a cGMP manufacturing facility, testing samples in the QC Microbiology laboratory for batch release of advanced therapeutics including cellular and gene therapy products.
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Support the cross-functional team with the circulation of documents for cross functional review, filing of documents in study working folders, and collation and QC of documents for the TMF submission.
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Ensure proper completion of QC and UAT of EDC tools and modules, including database testing, data export testing, and testing of custom programming. Clinical Data Management, eCRF, UAT, EDC, Medidata Rave, InForm, Medrio.
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Increase internal technical and operational capabilities to develop the radiochemistry platform focused on Pb212 including continuous monitoring, improvement and troubleshooting in the scope of radioprocess manufacturing, in process control including Radio-QC and release time.
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QC Microbiologist - Contract - Cambridge, MAProclinical is seeking a dedicated QC Microbiologist to support our vaccine manufacturing site. The QC Microbiologist will:Perform routine environmental monitoring of the manufacturing facility.
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Conducts library searches Performs administrative support duties as required Verifies accuracy of study forms Updates study forms per protocol Prepares data for analysis and data entry Assists with formal audits of data Documents patient visits and procedures Assists with regulatory binders and QA/QC procedures.
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qc job in Waltham, MA
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