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The Scientist is responsible for instrument validation/repair/maintenance from user side, reagents management, performing cell based assay and impurity assays according to and in compliance with Good Laboratory Practice (GLP), current Good Manufacturing Practice (cGMP), Code of Federal Regulations (CFR) and/or Points to Consider (PTC) guidelines and Standard Operating Procedures (SOPs.
Full-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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This role will host and lead health authority regulatory inspections for GLP, GCP, PV, GMP and GDP.Partner and lead cross functional business areas for inspection readiness activities, mock inspections, CAPA and post inspection/remediation.
ExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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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.
ExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Report any equipment and testing deviations to the Supervisor Submit samples for shipment to third party labs when necessary Maintain GMP/GLP laboratory notebooks and documentation relevant to the duties and responsibilities assigned.
Full-timeExpandApply NowActive JobUpdated 2 months ago - UpvoteDownvoteShare Job
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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. GCP, and GLP Quality Systems responsibilities include training, document management (SOPs and other controlled documents), change control, process improvement, and quality Quality systems activities will be coordinated with the Quality Systems group.
ExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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Extensive knowledge and understanding of clinical research, ICH, GCP, GLP, data management, regulatory and legal issues/processes as they relate to biomarker samples. At Genmab, we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases.
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If compliant with country laws) What you will do The Global Logistics Procurement (GLP) Co-op is responsible for partnering with GLP category leads and regional transportation and warehousing operations teams to provide input on supplier negotiations, inflation mitigation, sourcing events, contract implementation, and performance against established targets.
ExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Direct the junior chemists to prepare chemical protocols/reports/specifications/analysis certificates in compliance with cGMP/GLP. Provide technical support to junior chemists for troubleshooting/investigation during chemical study execution.
ExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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Summary The Scientist in the Nonclinical Disposition and Bioanalysis (NDB) within Nonclinical Research and Development (NCRD) will be responsible for executing all phases/aspects of the toxicokinetics (TK) support of toxicity studies [ie, exploratory and definitive/Good Laboratory Practice (GLP)], serving as a contributor scientist/principal investigator of toxicity studies, and executing pharmacokinetic (PK)/TK strategies to support the development of small molecules and biologics.
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Knowledge and understanding of drug development including regulatory requirements and quality standards applicable to nonclinical and clinical laboratories (e.g., GLP, GCP, ISO). By 2030, Genmab's vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO™) antibody medicines.
ExpandApply NowActive JobUpdated 4 days ago
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