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In addition, our pre-clinical vaccine program, VAX-A1, is moving into a period of high intensity focus in preparation for GLP and GMP work. Join our Mission to Protect Humankind Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked.
$124,000 - $138,000 a yearFull-timeExpandApply NowActive JobUpdated 2 months ago - UpvoteDownvoteShare Job
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The Associate Director/Senior Manager of Clinical Quality will develop, manage, and improve existing quality systems to ensure appropriate controls for EyePoint in-house GCP and GLP capabilities.
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Or in a Clinical Development role with expertise and/or transferable skills related to Good Clinical Practice (GCP), and/or Good Pharmacovigilance Practice (GVP). The GDQIM team is tasked with effective planning, preparation, conduct and follow-up of GCP, GVP and GLP inspections conducted by regulatory authorities.
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Review early-stage analytical testing in support of GLP and GMP clinical protocols and production activities. QA Issuance, Review and Approval of manufacturing production batch records in support of 300 BMK manufacturing operations Perform walkthroughs and other support activities of Analytical Science and Process Development to ensure compliance with applicable GMPs/GLPs. Review of GMP/GLP documentation from manufacturing and/or Analytical Operations, which can include logbooks, and test records.
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Knowledge of applicable GCP and GLP domestic and international regulations and guidelines for clinical trials. Strong acumen and demonstrated ability in GLP/GCP auditing , FDA and EMEA regulations inclusive of direct experience with Pharmacovigilance and System Development Life Cycle activities.
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Develop, qualify, and validate (as appropriate) bioanalytical assays (expressions assays including mRNA and protein [ELISA/IHC], anti-AAV capsid nAb, CTL IFN-γ ELISPOT, IgG/IgM, biodistribution and shedding) for all programs and define science-driven, phase appropriate, and risk-based analytical development strategies to support the development candidate during discovery through preclinical evaluation (including GLP) and clinical development advancement.
Full-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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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.
$145,000 - $165,000 a yearFull-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Extensive knowledge in cancer biology, broad technical expertise including direct experience in biomarker assay development/validation across major technology platforms, oversight at external CROs and specialty labs, and working in a global matrix of translational scientists and clinical scientists is required.
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AVEO continues to develop FOTIVDA in immuno-oncology combinations in RCC and other indications, and has several other investigational programs in clinical development. The VP QA will direct all GxP Quality activities and ensures Aveo and its vendors are inspection ready, adhere to GLP, GCP, GPV, GDP and GMP applicable regulations, company policies & procedures.
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Demonstrated expertise in GLP and GCP compliance of sample handling and storage, bioanalytical assay development, sample analysis, and laboratory operation and procedures is required. Experience must include a combination of laboratory and project management skills, including managing CROs for assay development and validation for clinical and non-clinical studies.
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We are seeking a highly motivated, collaborative, and innovative Associate Director of GLP/GcLP Compliance within the Clinical Assay, Supplies and Logistics (CASL) team who will be responsible for performing and overseeing QC activities within the Clinical Biomarker Laboratories (Immuno-Assays BioAnalytics, Virus Neutralization, Biobank, Flow Cytometry, Spectrometry, etc.
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R&D Strong knowledge and understanding of clinical drug development strategic planning of clinical research, ICF, ICH GCP, GLP is strongly preferred. TS has a broad remit stretching from support of discovery with human data to support target selection, through development of novel decision- making biomarkers for early phase clinical trials, target-centric indication sequencing and prioritization, and biomarker support of regulatory filings.
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Knowledge and understanding of clinical drug development strategic planning of clinical research, ICF, ICH GCP, GLP, In Vitro Diagnostic Regulation (IVDR) 2017/746, General Data Protection Regulation (GDPR) and clinical laboratory specimen handling.
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PhD in oncology with 5-8 years of industry related experience in biomarker assay development, with very good knowledge and understanding of design control process, analytical and clinical validation, manufacturing, GCP, GLP, and GMP requirements.
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Charles River also provides a suite of products and services to support our clients clinical laboratory testing needs and manufacturing activities. Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance.
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