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Defines strategy for and oversees tactical execution strategic plan by direct reports to provide effective oversight of research, assay development in support of pre-clinical and clinical research, GLP animal studies, in vitro diagnostic development, and all R&D vendors.
Full-timeExpandApply NowActive JobUpdated 1 month ago - 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.
Full-timeExpandUpdated 18 days ago - UpvoteDownvoteShare Job
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Partner with CMC, Clinical Development, Clinical Operations and Pharmacology to ensure GMP, GLP and GCP compliance for all clinical development programs by providing guidance. In close partnership with the Head of QA, as needed, oversee GMP, GLP and GCP compliance audits (US and international), including contract manufacturing sites, analytical testing sites, clinical storage and distribution sites, clinical investigator sites, contract test laboratories, and CROs to determine compliance status and to identify compliance risks.
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Minimum of 5+ years of progressive Quality experience working in regulated environment preferably in the field of biotechnology, biopharma, and/or cell/gene therapy (deep experience with GLP or GCP preferred.
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Description The Process Research(PR) group within Synthetic Molecule Process Development (SMPD) is a global team responsible for interfacing with Takeda’s Discovery functions (e.g. medicinal chemistry, DMPK, Drug Safety) with the goal of route identification and phase appropriate route development to deliver GLP Tox and Ph 1 GMP Drug Substance (DS.
$322,300 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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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.
$20 - $21ExpandUpdated 18 days ago - UpvoteDownvoteShare Job
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The ideal candidate would have experience following GLP/GCLP standards, LIMS experience, and previous experience in clinical trials and drug development. Manage the lifecycle of samples and carry out laboratory maintenance activities to ensure samples are handled with the highest degree of quality in the laboratory following GLP/GCLP standards, regulatory requirements, standard operating procedures, and safety practices.
Full-timeExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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Excellent working knowledge, understanding and experience with the practical implementation of FDA and EMEA regulations and guidelines in GLP, GCP and GXP environments. The VP, Quality will have end-to-end Quality responsibilities inclusive of leading GLP, GCP, and GMP functions.
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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) Plan and host regulatory inspections, as well as external GxP audits.
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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 22 days ago - UpvoteDownvoteShare Job
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Can streamline research by delivering operational and cost efficiencies through the strategic insourcing of GMP, GLP and non-GLP research services from discovery through safety assessment.
$32 an hourFull-timeExpandApply NowActive JobUpdated 22 days ago - UpvoteDownvoteShare Job
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Solid understanding of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) requirements and their application in a phase appropriate manner. Author technical reports and analytical Chemistry, Manufacturing and Controls (CMC) sections in regulatory documents.
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GMP, GLP, CPR, spill containment, IATA, DOT, IMDG, Hazwoper, and/or OSHA training is desired. Manage other lab-related services (i.e., freezer de-icing, BSC and incubator cleaning, glass wash and autoclave) to ensure their successful and timely completion daily.
Full-timeExpandApply NowActive JobUpdated 23 days ago - UpvoteDownvoteShare Job
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Ironwood is also advancing apraglutide, a next-generation, long-acting synthetic GLP-2 analog being developed for rare gastrointestinal diseases, including short bowel syndrome with intestinal failure, as well as several earlier stage assets.
Full-timeExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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Review and resolve denials Process referrals and submit clinical support documentation to insurance carriers File documentation into a patient's chart Pharmacy Technician Qualifications:Minimum of three years Pharmacy Technician experience with prior authorizationsCoverMyMeds experienceExperience with prior auths for anti-obesity medications, such as GLP-1 such as Saxenda, Ozempic, Wegovy, and Mounjaro.
$20 - $25 an hourRemoteExpandApply NowActive JobUpdated Today
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