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Experience with protein characterization, including peptide mapping and intact mass by LC/MS. Experience with HPLC, CE, icIEF, Empower software, Analyst software, Unifi software, Protein characterization, Peptide mapping Compliance with, and knowledge of, regulatory guidelines and company SOPs (CGMP, GLP) is required.
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Assisting as necessary with the internal GLP activities to conform with the GLP regulations (21 CFR Part 58) across the Medical Device CommunityMaintaining a copy of a master schedule sheet of all nonclinical laboratory studies conducted at Ethicon indexed by test article and containing the test system, nature of study, date study was initiated, current status of each study, identity of the sponsor, and name of the study director.
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In this dynamic role, you'll be at the heart of our formulation, fill, and finish activities, playing a key part in preparing a wide range of test articles for both non-GLP and GLP preclinical studies.
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Adhere to principles of GLP/GCLP applicable to bioanalytical sample testing, data analysis and reporting. Provide technical guidance and mentoring to bioanalytical testing staff and other team members as needed in the execution of bioanalytical projects as well as GLP/GCLP best practices.
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Job Summary: The Clinical Laboratory Scientist handles all hematology, coagulation, routine chemistry, immunoassay testing with a goal of providing 100% accuracy when processing samples. Performs all essential functions such as laboratory safety, Good Documentation Practice (GDP), Good Laboratory Practice (GLP), specimen processing and troubleshooting, maintaining productivity and quality assigned metrics, and providing effective communication with laboratory management and team.
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Experience reviewing regulatory documents, DMPK and BA reports, and non-GLP/GLP data and notebooks. Partner with Drug Metabolism and Pharmacokinetic (DMPK) and Bioanalytical (BA) Subject Matter Experts (SMEs) to author, review and track regulatory documents.
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Responsibilities:Primary role - Performing nonclinical writing tasks, such as:Experience in deadline driven bioanalytical environments that support preclinical GLP and non GLP studies. Good understanding of ICH guidelines for drafting bioanalytical reports, assay validation protocols for supporting gene therapy programs.
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Comprehensive knowledge of GLP regulations, including previous GLP experience in pharmaceutical or biotechnology industry or equivalent GXP transferable experience. Oversee and provide strategic direction for Toxicology/Pathology, BioAnalytical/DMPK, Biomarkers, and Clinical Pharmacology teams to ensure robust support for clinical development programs.
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Our team works on a diverse and exciting pipeline, participating in a wide variety of GLP-toxicology study types, many of which are run in-house, in addition to early discovery and investigative studies.
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We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development.
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Supports animal and human cadaver studies to help define clinically accurate use condition requirements for verification testing or to demonstrate that products meet requirements (GLP study.
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Design and manage preclinical studies (non-GLP and GLP) for inclusion in IND and BLA submissions, including pharmacology, biodistribution, immunology, and toxicology studies with estimated costs, timing, and risk assessment/management.
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The Senior Manufacturing Associate must follow written, approved procedures and forms to ensure all work is conducted “Right First Time” (RFT) following Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and/or Good Laboratory Practices (GLP.
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Brings decades of experience to accommodate a wide variety of GLP and non-GLP studies in all in vivo models and dose routes. Tissue trimming for microscopic examination, data recording and performing quality control reviews in accordance with Good Laboratory Practices (GLP.
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AmplifyBio brings decades of experience to accommodate a wide variety of GLP and non-GLP studies in all in vivo models and dose routes. - Microtomy, paraffin embedding, tissue processing, GLP documentation.
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glp testing jobs Title: associate test
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