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The Solid Dose Process Development Scientist will report to the Facilities and Engineering Manager in support of process development, scale up, and process validation. Author and review GMP documentation related to process development (protocols, Design of Experiments (DOEs), SOPs, Change Controls.
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Manage product process development through scale up and collaborate with the Validation team to complete process validation. AnazaoHealth compounds preparations for Age Management, Weight Management, IV Therapy, Sexual Health, Vitamin Injections, Hormone Replacement, Hair Care Solutions, Aesthetics and more.
Full-timeExpandApply NowActive JobUpdated 14 days ago - UpvoteDownvoteShare Job
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ELISA, HPLC, GMP, Stability Testing, Assay Development, method development, characterization, immunotherapy, assay validation, microbiology, environmental monitoring, cell based assay, potency assay, physico-chemical assays.
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Hands on experience in Implementation & Validation of various computerized systems like PCS (DeltaV) / BAS (Rockwell) / MES (Syncade) and Pi Historian / SCADA / PLC. Author, Review, Approve and Execute CSV life cycle documentation.
ExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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Oversight of assay verification, qualification, validation, and tech transfer activities. Author and review Quality Control Standard Operating Procedures (SOPs), Assay Qualification Reports, and Stability Protocols.
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Job Description: Validation Engineer III. Strong knowledge of Software Development Lifecycle (SDLC), including 21CFR part 11/Annex 11, Data Integrity and computerized system validation requirements.
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In addition, you will design, author and execute protocols, commission, install, and validate analytical equipment, for example, HPLC, GC, chromatography, and/or a carbon/Nitrogen Analyzer, and maintain such equipment.
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Author and execute study protocols governing bioanalytical studies to support in vivo studies and sample analysis. The Scientist will play a role in the design and qualification/ validation of study methodologies to support in vivo studies while supervising a team of up to 2 scientists.
Full-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Author, document, review quality record documentation including NC, RCI, FI and other areas of quality engineering/validation, spreadsheet validation, and equipment qualification.
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QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine.
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Computer System Validation experience with DCS, SCADA and BMS systems such as DeltaV, Factory Talk View, Desigo, Unicorn, Wonderware is preferred. Able to work independently with minimum guidance from Sr. Engineers and/or CSV Manager (author protocol, execute, analyze data, author reports.
Full-timeExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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In addition, you will design, author and execute protocols, commission, install, and validate analytical equipment such as HPLC, GC, chromatography, biochemistry analyzer, or a carbon/Nitrogen Analyzer, and maintain such equipment.
$95,000 - $100,000 a yearFull-timeExpandApply NowActive JobUpdated 26 days ago - UpvoteDownvoteShare Job
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Influence CMC regulatory strategy and author DP CMC sections of filing. It is the division’s leader in sterile product and process development, responsible for late-stage commercialization activities including process scale up, technology transfer to internal and external sites, process validation, authoring of regulatory submissions and support of significant manufacturing investigations.
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The Contractor shall author, assemble, coordinate, and schedule Counterintelligence / HUMINT asset validation events in support of HUMINT asset validation and HUMINT source management and provide recommendations to Government.
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Candidate should have previous extensive in vivo pharmacology/experimental therapeutics research experience in solid tumors supported by first-author publications it high-impact journals. Independently perform in vivo and in vitro studies for the validation and characterization of targets or therapeutic agents in oncology and tumor immunology.
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