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Thorough general knowledge of bioassay test methods (e.g. Elisa, Flow cytometry, qPCR, cell culture) Support Bioanalytical laboratory by execution of in-process and release testing on batches including, but not limited to, flow cytometry, IFNg potency, qPCR, cell count and viability, sterility, and endotoxin.
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Executes experiments and analyzes data from flow cytometry analytical assays with limited supervision, as part of the Cell Therapy Analytical Development (CTAD) team. Flow cytometry assay development experience is preferred.
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Experience with flow cytometry software is preferred: Flowjo, FCS Express. - Experience with flow cytometry platforms is preferred: Miltenyi Macsquant, Client Symphony A5 and/or Canto.
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Experience with flow cytometry platforms is preferred: Miltenyi Macsquant, Client Symphony A5 and/or Canto, Client Cytoflex. Experience with flow cytometry platforms is preferred: Miltenyi Macsquant, Client Symphony A5 and/or Canto, Client Cytoflex.
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Advanced knowledge of toxicology, pharmacology, safety pharmacology & DMPK. In this role, you will represent toxicology at cross-functional project teams, strategize nonclinical safety data package, oversee safety pharmacology and toxicology studies, author nonclinical sections in regulatory submission documents, and address regulatory inquiries.
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Working knowledge of technological platforms covering biomarker measures including but not limited to genomics, gene expression, immune profiling, and flow cytometry. Working knowledge of technological platforms covering biomarker measures including but not limited to genomics, gene expression, immune profiling, and flow cytometry.
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7 or more years of experience within pharmacovigilance, clinical pharmacology, preclinical research, toxicology and/or biomarker validation (especially in industry) required. 7 or more years of experience within pharmacovigilance, clinical pharmacology, preclinical research, toxicology and/or biomarker validation (especially in industry) required.
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Designs and develops clinical studies and research plans in support of asset strategy with the Early Clinical Development Leadership team; clinical studies include first-in-human Phase I, proof of concept Phase I/II, entry registrational studies, biomarker qualification studies, and/or clinical pharmacology studies.
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Track record in drug discovery/development in large or small biotech/pharmaceutical companies, leading translational/biomarker studies or innovative efforts to deploy technologies and assays for enhanced translational capabilities or similar skill sets in academia.
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Insmed is seeking a part-time scientist for the pre-clinical in vivo pharmacology group with prior experience in the maintenance and breeding of highly sensitive genetically modified mouse strains.
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An advanced understanding of anatomy, physiology, pathophysiology and pharmacology is required. On of the following preferred: CCDS, CDIP, CCS. An advanced understanding of anatomy, physiology, pathophysiology and pharmacology is required.
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The candidate will have a medical degree or a PhD in a life-science area like Biology, Immunology, Pharmacology, etc. Support the different functions within the Clinical Team with his/her expertise and leadership (monitoring, data management, biostatistics, medical writing, pharmacovigilance, regulatory affairs) as well as interact with and support Project team members, Clinical Immunology Laboratory, Budget and Planning Functions, Legal and Patent Department, Product Brand Leader and Medical Affairs.
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PhD in pharmacology or pharmaceutical sciences or PharmD with a clinical pharmacology research fellowship required. Responsible for all aspects of Clinical Pharmacology and Biopharmaceutics studies and model-based drug development plans, serves as QCP subteam leader / clinical pharmacology project team representative, supports Phase 2/3 clinical pharmacology objectives with high-level supervision, participates in due-diligence activities, and represents global function on study and project teams.
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At least 3 years of experience in all types of non-clinical studies (pharmacology, pharmacokinetics, toxicology, etc.) At least 3 years of experience in all types of non-clinical studies (pharmacology, pharmacokinetics, toxicology, etc.
Full-timeExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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Plays a key role in the interactions with regulatory authorities (e.g., FDA, EMEA meetings). Provides scientific input to the core documents for the project (e.g., product strategy documents, protocols, submissions, etc.
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histologist cytometry pharmacology jobs in Basking Ridge, NJ
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