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Be a thought partner providing scientific input for in vivo preclinical toxicology studies. This is a dynamic role participating in the advancement of preclinical research into the clinic, with particular focus on the execution of exploratory, pilot, and pivotal (GLP) toxicology studies.
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Ensure that GLP regulations and SOPs are followed in all bioanalytical service activities. Education, Experience & Skills Required: Ph. D. or Master’s degree in Analytical Chemistry, Biochemistry, Biology or related scientific discipline.
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This role supports a key shift in the way non-GLP integrated toxicology studies are managed in SA, aligning with the vision of the integrated toxicology (ITox) business model. We are seeking a Scientific Coordinator for our Safety Assessment (SA) site located in Stilwell, Kansas (KAN.
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QPS, LLC is an innovative and dynamic Contract Research Organization (CRO) that has been assisting pharmaceutical, biotechnology, and medical device companies with their drug development efforts by providing a full range of GLP-compliant bioanalysis, DMPK, and protein/genomic biomarker services since 1995.
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Serve as the SME for important toxicology/Safety topics in areas such as safety biomarker analysis, genetic, endocrine, reproductive toxicology, applications of scientific methods to delineate appropriate mode-of-actions on emerging safety issues and the assessment of human relevance of the nonclinical findings in support of the planned and ongoing clinical trials.
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Scientific Knowledge: A strong foundation in discovery sciences and protein biochemistry is essential. Master’s degree in biochemistry, molecular biology, biotechnology, or a related scientific discipline with at least 5 years’ experience; Ph. D. preferred.
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Overview Performs any basic to complex Analytical assay(s) according to and in compliance with Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP), Code of Federal Regulations (CFR) and/or Points to Consider (PTC) guidelines and Standard Operating Procedures (SOPs.
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The position will support bioanalytical method development, validation and application of bioanalytical assays within the Scientific Core Laboratories. Preference will be given to candidates with direct relevant experience in GLP bioanalytical chemistry.
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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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Master’s degree in Analytical Chemistry, Biochemistry, Pharmacology or related scientific discipline with 1+ years direct experience, OR Bachelor’s degree in same discipline with 4+ years direct experience.
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Experience in GMP pharmaceutical product testing and knowledge of GDP and GLP requirements. Or a doctorate from an accredited four-year college or University in chemistry, biochemistry, or a related scientific field with a preferred 1- 3 years of experience working in a laboratory in a manufacturing or academic setting.
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Provide Input on company policies, procedures, and documentation necessary to maintain compliance with the GLP guidelines and to ensure scientific rigor in the studies conducted on site [ Principal Study Director.
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Preferred: BS in scientific discipline, analytical chemistry with 0-2 years of experience in Pharmaceuticals, Medical Device or Radiopharmaceuticals, knowledge of HPLC and ICP-MS instrumentation, and previous work related to radiation pharmaceuticals, ability to conduct analytical assays with knowledge of cGMP, ICH, SP and other global compendial regulations and guidance.
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The Associate Scientist - QC Manufacturing performs and directs assays according to and in compliance with Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP), Code of Federal Regulations (CFR) and/or Points to Consider (PTC) guidelines and Standard Operating Procedures (SOPs.
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Lead and provide strategic direction for Surgery’s Preclinical Affairs efforts, including the scientific design, coordination, execution and reporting of biomedical animal research studies to aid in the design and development of medical devices for soft tissue repair/reconstruction, hemostat products and sealants.
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