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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.
$200,000 - $250,000 a yearFull-timeExpandUpdated Today - UpvoteDownvoteShare Job
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The QAU will support the comparable GMP production activities related to GLP toxicology lot production and technical transfer activities as it relates to clinical batch release testing conducted at GTP to support the clinical CMO. The QAU will also provide Quality Assurance support to the research-based portion of the GTP, in terms of SOP management, training, document management and archiving, and audit support.
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On the laboratory testing side, the SME will also be responsible for GMP testing of raw materials, in-process and finished products, stability sample testing, and non-routine sample analyses per established procedures and methodology, internal laboratory audits, maintaining cGMP/GLP compliance (audit readiness) within the QC chemistry laboratories.
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The Chemist II will support the Quality Control Laboratory in analytical testing in compliance with GMP and GLP requirements. Performs analytical testing pursuant to available qualified methods of analysis, including but not limited to: moisture analysis, tapped/bulk density, particle size via sieving method, UV-Vis spectrometry, FTIR spectrometry, TOC, HPLC and UPLC chromatography, dissolution, disintegration, weighing, etc.
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As a part of Clinical Trials Scientific Affairs, the Principal Scientist will support testing, method development and validation. Ensure all methods and validations are done according to all applicable regulatory guidelines, including but not limited to Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Clinical Laboratory Practice (GCLP), College of American Pathologists (CAP), Medicines and Healthcare Products Regulatory Agency (MHRA), Food and Drug Administration (FDA), International Organization for Standardization (ISO), etc.
$115,000 - $130,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Comprehensive knowledge of GLP regulations, including previous GLP experience in pharmaceutical or biotechnology industry or equivalent GXP transferable experience. Oversee and provide strategic direction for Toxicology/Pathology, BioAnalytical/DMPK, Biomarkers, and Clinical Pharmacology teams to ensure robust support for clinical development programs.
$265,000 - $300,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Perform and document raw material, in-process, and final release testing utilizing, but not limited to, protein concentration determination (BCA and absorbance methods), enzyme-linked immunosorbent assay (ELISA), sodium dodecyl sulfate-polyacrylamide gel electrophoresis (SDS-PAGE), high-performance liquid chromatography (HPLC), immunodiffusion, endotoxin analysis, pH, and bioburden.
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Ensure steadfast adherence to regulatory guidelines, GLP, and GMP practices throughout the analytical development lifecycle. Spearhead and supervise analytical development initiatives for small molecules, (including method development, validation, and testing in support of OSD.
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About Insourcing Solutions Charles River Insourcing Solutions℠ 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.
$39 - $41 an hourExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Communicates any testing nonconformances to Quality Manager, Manufacturing, or Process Development as necessary. The Junior Quality Control Analyst performs microbiological tests to ensure product quality and viability, under applicable GLP guidelines.
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Inspect and perform complex chemical analyses on raw materials, in-process samples, and finished goods in accordance with cGMP/GLP standard operating procedures. Relevant experience in good laboratory/manufacturing practices (GLP/cGMP), laboratory quality control or stability, and interaction with quality assurance is required.
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Solid knowledge of CRO, Biotech and Pharma industries with a grasp on bioanalytical, both GLP and non-GLP studies. Frontage Laboratories Inc. is an award winning, publicly listed (HKSE), full-service CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China, and growing over 30% YOY. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.
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The Senior Analyst / Scientist will also support the gene therapy program pipeline including but not limited to technical transfer, method qualification, validation, verification, routine GMP testing of AAV vector analytical methods (HPLC, AUC, UV, CE-SDS, compendia methods and other methods as needed) for lot release and stability.
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Brings decades of experience to accommodate a wide variety of GLP and non-GLP studies in all in vivo models and dose routes. Prepare study files for archiving per SOP, GLP and client specifications.
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Assist with performing non-destructive testing to ensure quality and detect defects; methods include: Visual Inspection, Ultrasound Testing, and Magnetic Particle Testing. Assist Technicians setup and calibrate non-destructive testing (NDT) equipment.
$16 - $22 an hourFull-timeExpandApply NowActive JobUpdated Today
glp testing jobs Title: analytical Company: Pci Services
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