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The Director, Drug Safety is responsible for planning, directing, coordinating and prioritizing activities of the product safety team and providing oversight of Pharmacovigilance (PV) vendors in all aspects of PV activities for products both marketed and in development.
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The Drug Product Development Intern will support the formulation development of protein biologics in the Drug Product Development (DPD) group. Drug Product Development Internship Overview.
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You will be responsible for providing, scientific leadership, and collaborative working environment to advance the drug candidates from IND through Phase IV. In addition, this position will collaborate with cross-functional stakeholders including in vitro & In vivo pharmacology, clinical biomarkers, DMPK, clinical development and operations, regulatory, CMC, and medical affairs.
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This is what you will do:Alexion’s Product Development and Clinical Supply (PDCS) organization is seeking an expert synthetic organic chemist to lead our strategic capability build in drug substance continuous processing, for deployment across an emerging small molecule portfolio.
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Provide front line and independent process development expertise for clinical and commercial drug product manufacturing operations during sterile processing, process characterization, tech transfer, process validation, and on-going commercial manufacturing.
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This position reports to the head of clinical pharmacology and toxicology and liaises with clinical development, clinical operations, non-clinical pharmacology and toxicology, and drug discovery to execute activities for advancing the development pipeline.
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Reporting to: Senior Director, CMC Regulatory Affairs, The Manager/Sr. Manager, Technical Writing - CMC (Chemistry, Manufacturing, and Controls) Regulatory Affairs plays a critical role in ensuring compliance with regulatory requirements pertaining to drug development and manufacturing processes.
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Simpson Strong-Tie's drug policy is based upon Federal Law, and therefore will screen applicants for amphetamines, including methamphetamines, cocaine, phencyclidine, opiates, and marijuana. As the Vice President, Market Development - Component Manufacturer, you will embody the role of a dynamic and strategic leader, dedicated to refining customer segmentation and orchestrating marketing strategies, including the execution of campaigns tailored to the Component Manufacturing Industry.
$256,500 - $320,600 a yearExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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FUJIFILM Cellular Dynamics is a leading developer and supplier of human cells used in drug discovery, toxicity testing, stem cell banking, and cell therapy development. Our proprietary manufacturing systems result in inventoried iCell products and donor-specific Custom Products in the quantity, quality, purity, and reproducibility required for drug and cell therapy development.
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Years Drug Safety/Pharmacovigilance experience. Advanced Tableau, Spotfire, Power BI, SAP Business Objects (BO) skills with + years of development experience. Knowledge and application of commercial coding dictionaries (MedDRA, WHO Drug.
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The Senior Scientist plays an integral role in the development and hands-on execution of critical projects that support the Heme Translational Medicine Department's aims in translational science, clinical trial support, and pre-clinical drug development.
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You will use your expertise in chromatography, spectrometry, spectroscopy, dissolution, and other established analytical methodologies to enable drug development utilizing external resources.
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Simpson Strong-Tie’s drug policy is based upon Federal Law, and therefore will screen applicants for amphetamines, including methamphetamines, cocaine, marijuana/THC, phencyclidine, and opiates.
$69,400 - $90,200 a yearFull-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process across multiple therapeutic modalities, including small molecules, biologics, and CGT products.
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In this vital role, you will be part of an innovative Medicinal Chemistry team with responsibilities centering around using Medicinal Chemistry principles to support the design and discovery of novel compounds for potential clinical drug development.
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drug development jobs Company: Cvs Health
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