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Work in collaboration with the Analytical Development team to ensure timely transition of lab developed methods to GLP ready state. 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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Thorough working knowledge of industry regulations, FDA and ICH guidelines; experience implementing and maintaining adherence to pharmaceutical and/or nutritional supplement GLP/GMP is strongly desired.
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The Analytical Scientist will be expected to validate new analytical methods with minimum to no supervision as well as to provide technical support to other corporate groups including Quality Control, Quality Assurance and International Business.
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A degree in analytical chemistry, biochemistry, chemical engineering or related fields is strongly preferred. A need to work on the bench to accomplish tasks along with the Analytical Chemistry team.
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Education and Experience A Bachelor’s degree with 7 years of experience in validation of analytical methods for nutraceuticals and/or pharmaceutical samples in a GMP environment. Roles and Responsibilities: Validation of analytical methods to ensure analysis and prompt release of raw materials, finished products, and stability studies.
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Design and execute method transfer protocols of analytical methods oriented to the timely manner release of product by the QC department. Maintains current knowledge of latest technological and scientific trends and serves as an analytical science resource for the rest of the group.
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Proficient in most of the laboratory instrumentation such as FTIR, HPLC, ICP, GC, UV-Vis, LC-MS, GC-MS, ICP-MS, HPTLC and test methods. Proficient in Empower Software and other laboratory software use in QC environment for chromatographic, spectroscopic methods as well as wet chemistry.
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He/She will also support testing required for drug substance and drug product process development, characterization of impurities, and other activities associated with GLP Toxicology and cGMP Clinical Trial materials.
$130,000 a yearFull-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Essential Duties & Responsibilities Apply and stay current on drugs and medical devices regulations, including USP, ICH and FDA regulations for cGMP and GLP independently. Knowledge, Skills & Abilities Knowledge Demonstrated proficiency in operating analytical laboratory instruments such as HPLC, GC, FTIR, pH, GC, UV-Vis spectrophotometry, TLC, Karl Fischer titration, rheometry.
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Knowledge of Food and Drug Administration's (FDA) Good Laboratory Practice (GLP) Regulations, 21 CFR Part 58 for the conduct of nonclinical laboratory studies. The Assistant/Associate Scientist is responsible for performing analytical testing using a variety of cellular and/or molecular biology analysis platforms.
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Our custom research and development approach is designed to integrate into services, including platform bridging, GLP toxicology material, and GMP manufacturing. The Quality Control Analytical Scientist II will develop, qualify, and perform analytical methods that are used to test and characterize GMP Raw Materials, In-Process Samples, Drug Substance and Drug Products.
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Proficient in analytical methods for chromatographic, spectroscopic, titrimetric, and wet chemistry analyses. A Bachelor's degree in Analytical, General Chemistry, Biochemistry, Chemical Engineering, or related field is strongly preferred.
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Performs specific duties and responsibilities based on Laboratory Standard Operating Procedures (SOPs), the Hazardous Material Safety Plan, Good Laboratory Practices (GLP), and current Good Manufacturing Practices (cGMPs), to ensure the consistency and quality of Thorne products as well as efficient operation of the Analytical Laboratory.
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10 years of experience performing analytical methods for nutraceuticals and/or pharmaceutical testing in a GMP environment. Lead technical support of transferring analytical methods to the Quality Control group.
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Keywords: Chemistry, Chemist, HPLC, GC, Gas Chromatography, Mass Spectrometry, Karl Fischer, cGMP, GMP, GLP, LIMS, Laboratory Technician, Quality Control, Pharmaceutical, SCM, pH, Dissolution, Disintegration, Compendial, Method Transfer, Method Verification, Method Validation.
$90,000 a yearFull-timeExpandApply NowActive JobUpdated 16 days ago
glp job Title: analytical
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