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Oversee GLP and non-GLP in vivo (e.g. rodent and non-human primate) studies internally or out-sourced from lead selection screening through lead candidate IND-enabling work. Its patent-pending and proprietary pluripotent stem cell differentiation technology platform TFome™ was developed in Professor George Church’s lab, a pioneer in synthetic biology, and allows for the development of unique cell therapies with significantly streamlined manufacturing, improved cell quality, efficiency and speed.
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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.
$26 an hourFull-timeExpandApply NowActive JobUpdated 12 days ago - 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-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Lead identification of assay requirements, lab selection, and contract development to ensure regulatory compliance according to GLP, GCP, and applicable global regulatory requirements such as CLIA and EU IVDR, and execution feasibility.
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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.
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Coordinate vehicle/formulation preparations for in vivo studies. Skills & Requirements: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.
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B.S. degree in chemistry, analytical chemistry, pharmaceutics, chemical engineering or material sciences. Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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Review and evaluate immunoassay bioanalytical results supplied by external CROs to ensure quality; review GLP and clinical BA assay validation protocols and reports. Review and edit GLP and clinical BA assay validation protocols, and reports.
Full-timeExpandApply NowActive JobUpdated 15 days ago - UpvoteDownvoteShare Job
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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.
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Taking guidance from the requirements of the good laboratory practice (GLP) and GMP, standard operating procedures, specifications and other documentation for the quality assessment and control products.
$200,000 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Proficiency with UPLC/HPLC and Empower Software. The candidate will work full time onsite and contribute to the execution of laboratory activities related to the transition of Client small molecule compounds from Discovery into Development in support of Blueprint Medicines pre-clinical and clinical programs.
$44 an hourExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Located in the suburbs of Boston & Cambridge, they are seeking an experienced Process Chemistry leader to design, execute, and lead chemical process development and manufacturing strategy to produce drug substances for GLP toxicology, clinical supplies and potential commercialization.
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In-depth working knowledge of the applicable cGMP/GCP/GLP/GVP regulations and guidelines in a pharmaceutical environment. This role will develop strong relationships, collaborate, and interact with various departments (i.e., Quality Operations, Quality Systems, Chemistry Manufacturing, and Controls (CMC), Analytical, Regulatory Affairs, Pharmacovigilance, Procurement), and all levels of management at Akebia to accomplish company objectives.
$189,501 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Independently execute quality assurance measures to lead compliance of in-house or outsourced non-clinical process development and analytics studies (e.g., GLP, non-GxP submission-related) with applicable regulations and Takeda standards.
$209,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Provide quality assurance oversight of GCP, GLP, and GMP operations for both internal and external production and use of regulated therapeutics products (ATMPs) Demonstrated experience establishing a quality organization and managing GMP/GCP/GLP staff.
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glp job Company: Pci Services in Cambridge, MA
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