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This role reports to the Director of Cell Therapy Process Development and will work in close collaboration with the Technology Transfer, MSAT, Analytical Development, Drug Product, Program Leadership and Manufacturing teams to develop client processes, execute process characterization and IND/BLA enabling studies.
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Lead the development and maintenance of KPIs, processes and procedures for the drug safety function. Oversight and management of Drug Safety operations' staff responsible for case management and ensuring process optimization, case quality, and accurate regulatory reporting.
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The incumbent will be responsible for establishing and maintaining a solid understanding of current industry trends with ADC payload linker and conjugation technologies, support due diligence projects for antibody-drug conjugates (ADCs) assets, interacting with internal and/or external research and development groups to support pre-clinical study material generation, and support clinical phase conjugation process development and technology transfer activities as needed.
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Recovery Centers of America (RCA) was created in pursuit of one goal: Help 1 million patients achieve a full life of recovery by providing evidence-based alcohol and drug addiction treatment, as well as eating disorder treatment.
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Successfully use the automation assets for rapid drug molecule screening and analytical development in order to reduce design selection risks and enhance product design across all phases of development.
Full-timeExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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Strong knowledge of key pharmaceutical functions throughout all stages of product development, including Marketing (e.g., Market Research, Market Access), HEOR, Medical Affairs, Preclinical, Clinical, Regulatory, CMC (e.g. supply chain, drug delivery), etc.
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Ability to demonstrate a broad understanding of the end-to-end drug and diagnostic development process, and specific expertise in oncology, preferably immuno-oncology. + Project experience in biomarker discovery, biomarker and diagnostic development, and early or late drug development is desired.
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Developing projects/platform specific biopharmaceutics knowledge (integrated in-vivo, in-vitro, and in-silico understanding) to support the design and development of exceptional patient focused drug products (e.g., oral, long-acting injectables, implants and biologics.
Full-timeExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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At UBC, we provide services to enhance the entire drug development process and commercialization lifecycle - from clinical trial support to real-world evidence generation. Target Buyers: Drug Safety, Pharmacovigilance, Regulatory Affairs, Medical Operations.
Full-timeExpandApply NowActive JobUpdated 30 days ago - UpvoteDownvoteShare Job
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This position supports statistical programming activities for late stage drug/vaccine clinical development projects. US and/or worldwide drug or vaccine regulatory application submission experience including the development of electronic submission deliverables.
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The Associate Director, R&D Project Planning Capability Lead, is a member of CSL R&D’s Project and Portfolio Operations team responsible for advancing R&D’s project planning and schedule management practices to support the delivery of our drug development pipeline.
Full-timeExpandApply NowActive JobUpdated 19 days ago - UpvoteDownvoteShare Job
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Solid understanding of the cross-functional drug development process including specific to clinical trial operations, data management, statistics, etc. Please know that Madrigal does not conduct interviews via text or in chat rooms; conduct interviews via Skype, RingCentral or solely via telephone; charge candidates an advance fee of any kind (e.g., fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough recruiting process.
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The experienced and motivated Senior Associate Scientist will be responsible for development, validation, and transfer of HPLC and Capillary Electrophoresis analytical methods for protein biotherapeutics, including monoclonal antibodies, antibody drug conjugates, and novel modalities.
Full-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Provide oversight to the development of Model Informed Drug Development (MIDD) plans, involving planning and execution of quantitative analyses which may include population pharmacokinetics, pharmacokinetics (PK)/pharmacodynamics (PD), exposure response, disease progression modeling, model-based meta-analysis, and decision analysis.
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Conduct laboratory research related to drug delivery, development of nanoparticle-based formulations, and characterizations for, but not limited to Ocugens products. The role of Research Scientist, Drug Delivery & Nanotechnology involves leading and conducting experiments for the discovery and preclinical activities of Ocugens product pipeline related to nanoparticle-based drug substances.
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drug development jobs in Norristown, PA
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