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Amgen is currently seeking a Process Development Sr Principal Scientist in our Pivotal Attribute Sciences Department in Cambridge, MA. This team plays a crucial role in pivotal phase analytical development, including method development, validation, transfer, process and product development support, and GMP testing of drug substances and drug products.
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Knowledge of cGMP practices as applicable to technology transfer, manufacturing, drug substance, and analytical development. We provide ample scientific challenges enabling you to have a real impact in an environment where you get the opportunity to take part in the entire biotech value chain from the earliest drug discovery all the way through late-stage clinical development and eventual commercialization.
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Development, optimization, qualification, transfer, validation, and routine execution of analytical methods for proteins, mAbs, drug conjugates using techniques pertinent to LC (SEC, RP, IEX), LCMS, ELISA, CE-SDS, icIEF, and other wet chemistry techniques.
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They will work within the Analytical Development team to characterize drug substance, drug product, impurities, degradants, and metabolites from pre-clinical research through drug development and commercialization.
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Development and implementation of advanced data analytics and state-of-the-art machine learning models to generate insights from proteomics (ABPP) data, protein structure, and protein dynamics to enhance target prioritization and structure-based drug design efforts.
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Strong knowledge of pharmacokinetics and pharmacodynamics principles, immunogenicity, modelling and simulation, Model-Informed Drug Development, ADME Concepts, and regulatory clinical pharmacology requirements to support clinical development and regulatory submission.
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Technical Client Solutions/Data Engineering/Product Development, AVP - Hybrid. We are seeking a Technical Product Development Assistant Vice President to help us take our BI offering to the next level.
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Analytical Skill, Analytical Skill, Analytical Thinking, Chemical Biology, Chemistry, Clinical Trials, Collaboration, Communication Skills, Curiosity, Data, Data Analysis, Design Of Experiments, Detail-Oriented, Drug Development, Drug Discovery, Ethics, Gene Therapy, Immunology, Inventory Management, Laboratory, Lifesciences, Machine Learning (Ml), Management, Medical Research, Molecular Biology {+ 10 more.
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These qualifications and responsibilities will enable the Senior Director, Protein Engineering, to successfully lead the protein engineering teams across multiple sites, drive innovation, and contribute to the success of drug development initiatives at BMS.
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Provides ad-hoc programming support to Clinical Operations, Data Management, Statistical Programming, Biostatistics, Drug Safety, Clinical Science, Medical Writing and Drug Safety to ensure rapid access to clinical study data for data cleaning/validation, SAS listings review, TLF, dry runs, etc.
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The Talend ETL Developer is a key member of CHIA’s software development organization and our Data Operations and Technology team reporting to the Associate Director of Master Data Management and ETL Design.
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3 years as a Clinical Trial Scientist or comparable role Strong familiarization with Good Clinical Practice (GCP) and drug development processes, ideally Phase 1 - 3; ideally paired with experience in Oncology / Immuno-Oncology Good knowledge of set-up, organization and execution of global clinical studies in a pharmaceutical company or contract research organization (CRO), or comparable experience within academic research institution.
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Provides oversight of case processing activities for the Xenon clinical development program and serves as safety data management subject matter expert (SME) on regulations and best practices for conventions and handling of safety data in Xenon’s global safety database (GSDB.
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Affini-T Therapeutics is announcing a Senior Director, Head of Product Sciences opportunity at our headquarters in Watertown, MA. Position Summary The Head of Product Sciences role is situated within the larger CMC organization responsible for process development, analytical development, technology transfers, manufacturing, and supply of our drug product TCR T cell candidates, drug substance and critical intermediates such as gene editing reagents, viral (LVV) and non-viral vectors.
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Lead internal and outsourced development and qualification or validation of biomarker assays for clinical trials, applying experience across relevant methods (e.g. qPCR, digital drop PCR, Western blotting), to develop robust assays, generate and analyze data and provide expert interpretation of the effects of promising drug candidates.
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data drug development jobs Title: president in Watertown, MA
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