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Solid knowledge of CRO, Biotech and Pharma industries with a grasp on bioanalytical, both GLP and non-GLP studies. The areas of focus include Medicinal Chemistry & CDMO, Drug screening, DMPK, Safety Toxicology and Bioanalytical services.
Full-timeExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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These positions will support the growth of Frontage global business, including both U.S. and China, by seeking and expanding US biopharma, biotech and institution clients Depending on the experience, the areas of focus include a combination of the following: Medicinal Chemistry, CMC & CDMO, Drug screening & Biology, Pharmacology, DMPK, and Safety & Toxicology.
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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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Lead the development and execution of GLP and non-GLP toxicology study designs; critically review and edit nonclinical toxicology study reports, and coordinate report finalization with CROs.
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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.
$29 - $32 an hourFull-timeExpandApply NowActive JobUpdated 17 days ago - UpvoteDownvoteShare Job
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Prior hands-on experience in a regulated bioanalytical laboratory (GLP/GCP/GCLP) is a plus. Quality-oriented - Prior experience in a regulated bioanalytical laboratory (GLP/GCP/GCLP) is a plus.
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Thorough understanding of regulatory guidelines related to global submissions and submission content (e.g., FDA/EMA/PMDA regulations; ICH guidance; GLP/GCP requirements; SEND requirements, etc. Leads nonclinical submission working groups to liaise effectively with cross-functional team members (Clinical, Global Patient Safety, Program Management, Global Regulatory, Regulatory Operations, Drug Discovery Units, DMPK&M, and Drug Safety Research and Evaluation) to recognize aims, align on strategy, define executable timelines, and agree upon content for nonclinical regulatory submissions.
$170,500 a yearFull-timeExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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The VP QA will direct all GxP Quality activities and ensure Aveo and its vendors are inspection ready, adhering to GLP, GCP, GPV, GDP, and GMP applicable regulations, company policies & procedures.
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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.
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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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Experience in pharmaceutical or biotech product development across numerous modalities, with direct involvement in regulated studies related to pharmacology, toxicology, or pharmacokinetics, demonstrating a broad understanding of the drug development process.
$170,500 a yearFull-timeExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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Design GLP studies to determine safety/tox and build the preclinical data package for clinical candidate nomination. Manage and mentor a team of scientists, ensuring leadership and oversight for development and implementation of in vitro assays as well as for in vivo preclinical efficacy, safety and PK/PD studies.
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Troubleshooting and data review/interpretation will be needed in this role while working in compliance with cGMP/GLP, safety and regulatory requirements. Experience with other synthetic techniques below is a plus- Dissolution, UV-Vis, FTIR, NMR, GC, LCMS etc.
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Proven track record of success in a fast-paced production environment at a biotech/pharmaceutical company preferably in GMP or GLP. At least 5 years of QA or Manufacturing experience in a GMP manufacturing environment with a Bachelor’s Degree in Biology, Chemistry, Chemical engineering, Biomechanical engineering, Bioengineering, Biomedical Engineering, Biochemistry or related field.
Full-timeExpandApply NowActive JobUpdated 2 days 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.
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glp job Company: Aequor in Boston, MA
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