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Manage manufacturing activities for viral vector and cell therapy, including cGMP aseptic qualification, in support of manufacturing and formulation of viral vectors as drug substance and of cell therapeutics as drug products.
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Extensive experience in late phase drug product development and commercial development with CMC regulatory filings for US (NDA), Europe (MAA), Japan, and China. Playing a critical role as the subject matter expert (SME) and project lead of Pharmaceutical Development within CMC function, the position will be responsible for preformulation studies, formulation and process development, drug delivery design, optimization, scale-up and manufacturing in support of Revolution Medicines pipeline compound development and clinical programs.
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Understanding of standard drug development process, defining in vivo pharmacology, assessing PKPD and deriving margins to provide clinical starting doses. Conceptualize and design strategies for drug discovery using insitro's platforms from hit to lead using industry standard preclinical pharmacology models and standard drug development models by applying insights exposed by insitro's unique target discovery credentialization.
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The Senior Director, Drug Safety & Pharmacovigilance will be responsible for building and leading the safety and pharmacovigilance efforts for the Clinical Development organization. Interact with and / or supervise Drug Safety / Pharmacovigilance CROs.
$305,000 - $362,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Clinical staff members assist clients in their recovery from substance use and co-occurring disorders through counseling, education, role modeling, and empathetic trauma-informed support using the Seeking Safety framework.
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Requires a minimal of 5+ years in genomics, synthetic biology, or drug development. This individual will be responsible for driving product and application-based messaging across Twist’s business units, including core initiatives toward cancer research, drug discovery, and human genetics.
$120,000 - $170,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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As a Scientist in the medicinal chemistry group at Hexagon Bio, you will work closely with the natural products chemistry and biology teams to launch new drug discovery projects and have the opportunity to serve as a functional area project leader from project initiation through investigational new drug (IND) filing.
$140,000 - $205,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Strong understanding of science and drug development, with specific expertise in nonclinical study design, preclinical CROs, data management systems, nonclinical study procedures, and statistical analysis methods.
$265,000 - $300,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Albertsons Companies is a leading food and drug retailer in the United States. The Company operates stores across 34 states and the District of Columbia with 24 banners including Albertsons, Safeway, Vons, Jewel-Osco, Shaw's, Acme, Tom Thumb, Randalls, United Supermarkets, Pavilions, Star Market, Haggen, Carrs, Kings Food Markets and Balducci's Food Lovers Market.
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The Process Engineer will be responsible for providing drug delivery device production innovation support to project teams industrializing combination drug delivery devices for parenteral pharmaceutical therapeutics at Genentech.
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Clinical data management systems - eCOA, IRT, and industry wide thesauri, such as MedDRA and WHO Drug. Adverum’s core capabilities include clinical development, novel vector discovery and in-house manufacturing expertise, specifically in scalable process development, assay development, and current Good Manufacturing Practices quality control.
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The Clinical Trials Management Associate will work closely with Technical Operations to ensure drug product quality and delivery, Translational Sciences to ensure timely site biomarker sample collection and shipments, and support the clinical operations team with TMF filing and other duties as assigned.
$93,500 - $114,500 a yearFull-timeExpandApply NowActive JobUpdated 16 days ago - UpvoteDownvoteShare Job
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This well known and well established agency provides psychiatry, medication management, outpatient substance use treatment, case management, supportive housing, LGBTQ youth and youth care. This well known and well established agency provides psychiatry, medication management, outpatient substance use treatment, case management, supportive housing, LGBTQ youth and youth care.
$400,000 - $420,000 a yearExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Bexotegrast has received Fast Track Designation and Orphan Drug Designation from the U.S. Food and Drug Administration for both idiopathic pulmonary fibrosis (IPF) and primary sclerosing cholangitis (PSC) and Orphan Drug Designation from the European Medicines Agency in IPF and PSC. Pliant is currently conducting BEACON-IPF, a Phase 2b/3 trial of bexotegrast for the treatment of IPF and INTEGRIS-PSC, a Phase 2a trial of bexotegrast for the treatment of PSC.
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Review documents associated with drug substance and product development and manufacturing, including but not limited to change controls, methods, monographs, protocols, and reports, and organize and archive documents in Veeva Quality Docs System.
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drug alcohol substance jobs in San Mateo, CA
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