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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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Good understanding of regulations and GCP & GLP requirements for drug development, advanced knowledge of Electronic Data Capture/related applications and industry standards, Risk Based Monitoring, and advanced skills partnering with CROs and other third-party vendors.
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May assure compliance to in-house and/or external specifications and standards (e.g., GLP, GMP, ISO, Six Sigma). Lean Six Sigma Green Belt or higher is also preferred. Knowledge of manufacturing processes (e.g., welding, injection molding, machining, sterilization) preferred and Lean Six Sigma methodology.
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Experience with GLP (Good Laboratory Practice) and non-GLP toxicology studies. Associate Director, Toxicology - Cell & Gene TherapyAre you a seasoned Toxicologist ready to influence the future of Cell & Gene Therapy (CGT.
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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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Demonstrated expertise in GLP and GCP compliance of sample handling and storage, bioanalytical assay development, sample analysis, and laboratory operation and procedures/processes is required.
$112,000 - $163,000 a yearTemporaryExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Ensure that GLP regulations and SOPs are followed in all bioanalytical service activities. Good knowledge and application of GLP with the ability to train technical personnel. 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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Have working knowledge of bioanalytical assay development and qualification/validation requirements, ICH GLP, and GCP guidelines. Have working knowledge of bioanalytical assay development and qualification/validation requirements, ICH GLP, and GCP guidelines.
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The Staff Scientist will spearhead the following tasks 1) Planning experiments using current assays and panels assuring adherence to deliverables and time sensitive deadlines 2) Validation of new assays and optimizing existing workflows following standard operating procedures and 3) detailed record keeping of current projects 4) assuring GLP-like implementation of high rigor and assay reproducibility.
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Vir is seeking a Senior Scientist I, Bioanalytics who will develop bioanalytical methods to support our large molecule assets. Experience must include a combination of laboratory and project management skills, including managing CROs for assay development and validation for clinical and non-clinical studies.
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Familiarity with 21 CFR Part 11, the GxP's including GLP, cGMP, GCLP, and GCP, and computerized system validation is preferred. Our global reach, including a clinical research network in five countries in sub-Saharan Africa and in India, has allowed us to make fundamental contributions to understanding the epidemiology, transmission, virology, and immunology of HIV. This work played a key role in facilitating the design of promising HIV vaccine candidates, as well as the discovery of broadly neutralizing antibodies that are now being advanced as promising approaches for HIV prevention.
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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.
$185,000 - $200,000 a yearExpandUpdated Today - UpvoteDownvoteShare Job
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Theoretical knowledge of subject matter, cGMP, FDA guidelines, GLP and USPs. Complete knowledge of good analytical and laboratory techniques, basic knowledge of cGMPs, GLPs, SOPs, USP and FDA requirements.
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Knowledge of process validation (IQ, OQ, PQ), analytical instrumentation, FDA regulatory requirements (GLP/CMP/QSR), Risk Management / HACCP concepts, statistical process control, and statistical problem solving.
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The candidate should possess an in-depth understanding of safety pharmacology, investigative and regulatory toxicology, and have experience designing and critically evaluating results of exploratory and GLP-compliant toxicology studies.
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