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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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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.
$45 - $48 an hourExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Experience overseeing the establishment of biomarker assays at CROs in a GLP, GLP-like or CLIA environment required. 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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The incumbent will provide leadership for the performance of the Small Molecule, Large Molecule and Central Lab functions at the WuXi NJ site, lead the team in bioanalytical sciences, GLP operations, and business aspects, and to collaborate with WuXi’s Bioanalytical and Central Labs in China to promote synergy in supporting global clinical and non-clinical studies.
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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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The role requires expertise in current Good Manufacturing Practice (cGMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and relevant regulations across multiple jurisdictions. The Sr. Director, Quality Assurance will be responsible for implementing GxP (GCP/GLP/GMP) compliant Quality Management Systems, performing all required functions of the Quality Unit (ie product release) and building a Quality Assurance organization that fosters a strong Quality culture at Be Bio. This position will partner equally with both internal and external stakeholders and partners (CROs, CDMOs.
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The ideal candidate should possess a strong background in chemistry, have a thorough understanding of cGMP, GLP, GDP guidelines, and be proficient in utilizing analytical instruments such as FTIR, HPLC, and ICP. Additionally, the Lab Chemist will collaborate closely with third-party laboratories, manage sample submissions, and generate Certificates of Analysis (COAs) to meet industry standards and regulations.
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Knowledge of regulatory guidelines and requirements for conducting in vivo studies, including Good Laboratory Practices (GLP) and Institutional Animal Care and Use Committee (IACUC) regulations.
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The Molecular Technologist 1 will process customer samples in the microbiology laboratory utilizing the various technology platforms including but not limited to bacterial 16S rDNA and fungal ITS2 sequencing, MALDI-TOF mass spectrometry and ribotyping.
$21 - $22 an hourFull-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Can streamline research by delivering operational and cost efficiencies through the strategic insourcing of GMP, GLP and non-GLP research services from discovery through safety assessment.
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Familiarity with GLP, OSHA guidelines, FDA, BAM, APHA, ISO, and USP methods and procedures. Certified Group includes Food Safety Net Services (FSNS), Certified Laboratories, EAS Consulting Group, Labstat International Inc., Advanced Botanical Consulting & Testing (ABC Testing Inc.), Microconsult Inc., and Micro Quality Labs Inc. Certified Group provides laboratory testing and regulatory consulting services in the food & beverage, dietary supplements & NHP, cosmetics, OTC, tobacco, nicotine, cannabis, hemp, and other industries.
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Follows internal SOPs and ensures CROs are following current regulatory guidance in the development, validation and execution of GLP bioanalytical assays. Prepare documents and protocols for method transfer of assays to GLP/GCP approved CROs.
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Support all bioanalysis efforts for preclinical and clinical studies, including biological activity, pharmacokinetics, pharmacodynamics, and immunogenicity analysis of antibody drug molecules. Support the development of assays to measure the in vitro and in vivo interaction of biopharmaceutical drugs with their cellular targets.
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Characterize biotherapeutics by developing biosensor assays to quantitate antibody-target binding (e.g. kinetics, affinities) with high-throughput screens on various biosensor platforms. Research Scientist II - Biosensor.
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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. Job Segment: Database, Toxicology, Biotech, Pharmaceutical, Science, Technology, Research.
ExpandApply NowActive JobUpdated 21 days ago
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