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The successful candidate must have deep understanding of eQMS software development life cycle (SDLC) in a regulated environment (i.e., cGMP, GCP, GLP) with strong project management and business process analysis skills, and direct experience managing Document Control in a regulated environment.
Full-timeExpandApply NowActive JobUpdated 16 days ago - UpvoteDownvoteShare Job
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Generate detailed and accurate laboratory (ELN) records, follow good laboratory and GLP-like practices and ensure proper archiving of pathology specimens. Setup and perform routine pathology staining techniques including H&E, IHC and special stains using manual and automated platforms (Ventana and Leica.
Full-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Screen excipients/formulation vehicles for solubility and stability to optimize preclinical formulations to enable non-GLP and GLP pre-clinical studies. Execution of analytical experiments with XRPD, DSC, TGA, DVS, SEM, optical microscopy and UPLC/HPLC (Empower.
Full-timeExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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Coordinate vehicle/formulation preparations for in vivo studies. B.S. degree in chemistry, analytical chemistry, pharmaceutics, chemical engineering or material sciences. An ideal candidate will have a strong foundation in analytical techniques such as UPLC/HPLC (Empower proficiency) and an understanding of early drug development processes and experiments.
$44 an hourExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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The Quality organization at Mural is dedicated to ensuring compliance and excellence across all research and development activities, encompassing Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Pharmacovigilance Practice (GvP), and Good Manufacturing Practice (GMP.
Full-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Minimum of 5+ years of progressive Quality experience in a regulated environment, preferably in biotechnology, biopharma, and/or cell/gene therapy (deep experience with GLP or GCP preferred). This individual will report to the Sr. Director of Global GCP/GLP compliance and will work closely with the US Site VP and the Global Quality team.
ExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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The incumbent (“Toxicologist”) will report directly to the Head of Nonclinical Safety, Translational & Bioanalytics and will be responsible for contributing to the design and conduct of nonclinical safety assessment programs, with emphasis on discovery/early and GLP toxicology study support, to enable progression of novel therapeutic agents through the drug development process, regulatory approval and post-marketing activities.
$175,000 a yearFull-timeExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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Ensures all relevant quality and regulatory requirements are met for good clinical practices (GCP), good laboratory practices (GLP), good pharmacovigilance practices (GVP) and clinical site and vendor compliance with GxP regulations issued by FDA, MHRA and other applicable regulatory bodies.
Full-timeExpandApply NowActive JobUpdated 25 days ago - UpvoteDownvoteShare Job
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A full-service provider, we provides Sanger DNA sequencing, gene synthesis, molecular biology, high throughput/next generation sequencing, bioinformatics, and GLP regulatory services. A full-service provider, we provides Sanger DNA sequencing, gene synthesis, molecular biology, high throughput/next generation sequencing, bioinformatics, and GLP regulatory services.
Full-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Provide strategic leadership in defining the vision, framework, and requirements for the R&D archival program, working across the global enterprise with key stakeholders (e.g., in Research, Global Quality, Pharmaceutical Sciences, Plasma-Derived Therapies) to implement, as well as ensure execution and compliance to Takeda standards and global Good Laboratory Practice (GLP) regulations [e.g., 21 CFR Part 58; OECD (Organization for Economic Co-operation & Development) Principles of GLP.
$266,200 a yearFull-timeExpandUpdated Today - UpvoteDownvoteShare Job
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Design and oversee the implementation of quality systems specifically for CMC development activities, including the release of products for GLP and GCP studies. Establish robust processes for the review and release of products intended for GLP and GCP studies, ensuring data integrity and compliance.
Full-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Leads the development of quality and compliance strategies for support of global health authority GCP, GVP, GLP, GCLP inspection activities. Maintains in-depth knowledge of governmental regulations affecting GCP, GVP, GLP in the drug development process.
Full-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Knowledge of GLP/GCLP and GCP global regulatory requirements for clinical trial submissions (USA, UK & EU), understanding of 21CFR Pt. 11 with respect to clinical systems (QMS). Extensive experience managing deviations, RCA and CAPAs in a GLP/GCP environment.
Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Skills & Requirements:B.S. degree in chemistry, analytical chemistry, pharmaceutics, chemical engineering or material sciences. Proficiency with UPLC/HPLC and Empower Software. Perform drug substance and formulation stability studies to ensure optimal formulation design.
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Demonstrated knowledge and full understanding of GLP regulatory requirements, Standard Operating Procedures (SOPs), company practices, and industry standards. Experience managing CROs. Demonstrated knowledge and full understanding of GLP regulatory requirements, Standard Operating Procedures (SOPs), company practices, and industry standards.
Full-timeExpandApply NowActive JobUpdated Today
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