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Oversee assay transfer to QC or at contract testing organizations used for release testing of viral vectors used as raw material or final product in GLP animal and GCP human clinical studies.
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Oversee and provide strategic direction for Toxicology/Pathology, BioAnalytical/DMPK, Biomarkers, and Clinical Pharmacology teams to ensure robust support for clinical development programs. 12+ years of experience in the biopharma industry in non-clinical development (toxicology, pharmacology, pharmacokinetics, bioanalytical sciences, or related discipline.
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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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The Director, Quality Assurance, will manage a GLP QAU, including Good Laboratory Practice / Good Manufacturing Practice (GLP/GMP) within the Gene Therapy Program (GTP) at the University of Pennsylvania, supporting the development, manufacture, and testing of viral vectors for clinical trials.
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The Assistant/Associate Scientist is responsible for performing analytical testing using a variety of cellular and/or molecular biology analysis platforms. AmplifyBio brings decades of experience to accommodate a wide variety of GLP and non-GLP studies in all in vivo models and dose routes.
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Knowledge of laws, regulations, policies and guidelines that govern animal research, research conduct principles (GLP) and current methodology of laboratory animal medicine and management is important.
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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.
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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. Shrewsbury, MA, US, 01545 For 70 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies.
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Amgen is currently seeking a Process Development Sr Principal Scientist in our Pivotal Attribute Sciences Department in Cambridge, MA. This team plays a crucial role in pivotal phase analytical development, including method development, validation, transfer, process and product development support, and GMP testing of drug substances and drug products.
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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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Study Directors are responsible for the interpretation, analysis, documentation, and reporting of study results for GLP and non-GLP studies. The Study Director, Research Scientist will have a passion for preclinical research.
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Medical device, new product introduction, cnc machine, cnc programming, mechanical engineering, new product development, new product design, new product implementation, new product testing, product development process, process development, process improvement, machining, bom generation, erp system, pfmea, gage rr, manufacturing process, Design, work instruction, Solidworks, Npi, Lean manufacturing, iso 13485, six sigma, machine shop, tooling & fixture design, cam programming, milling machine.
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Familiar knowledge of GLP and GMP requirements as they pertain to protein and gene therapy process development and Quality Control (QC) testing is a plus. Authors and reviews the documents for the development and establishment of analytical methods for product characterization to support research and development activities including the in-process and release testing for material manufactured for research and IND-enabling studies.
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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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The Quality Control Analyst position performs testing and inspection of raw materials, in-process and finished products, and audits the corresponding documentation in compliance with internal SOPs and applicable regulatory requirements, participates in test method validation development and execution, and assists in the training and development of new Quality Control Analysts.
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glp testing product development jobs Company: Ascend Advanced Therapies
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