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Strong subject matter expertise in immune-oncology, cell therapy drug discovery and development including CMC considerations, CAR design, engineering and armoring strategies, innate immune cells such as NK and gamma delta for the purposes of leading drug development projects from start to the clinic.
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Deliver impactful outcomes by leveraging a deep understanding and experience in navigating typical workflows within drug discovery, drug development, gene-to-antibody, and proteomics.
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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, 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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Collaborate with CRO and academic partners; employ cutting-edge in vitro and in vivo animal and human models to advance drug discovery and development programs up to and including IND filing.
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Experience in cancer biology, working in oncology drug discovery project teams, cancer cell-based assay design, assay development and drug testing. Contribute to target validation to ensure the development of a robust preclinical pipeline of impactful drug discovery programs.
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Experience in collaborating with process development, QC/AD and supply chain/logistics functions in assuring supply of necessary components to assure drug substance timelines are met. The Sr Manager/Associate Director of Technical Operations oversees new process implementation and scale-up, manages data review, CMO relationships, and technical aspects of substance development.
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The Alloy Global Bioanalytics group provides bioanalytical support to all Alloy activities, including assay development, quality control and high-throughput characterization of antibodies, TCR mimics.
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Provide and present results in consultation with supervisor to support drug substance and drug product development. Process Development Senior Associate, Analytical Chemist.
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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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Must be proactive, self-motivated, highly flexible, with excellent communications skills (verbal, written, and presentation skills) to develop new relationship with oligo and peptide clients from screening up to preclinical stage of drug development in biotech and big pharma market in US.
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Exceptional matrix team leader, ability to interface with leaders across the enterprise and project teams to develop long range plans and budgets for clinical biomarker pathology technologies aligned with company objectives, identify, pilot and establish new pathology related technologies to meet drug development needs in Ph 1, Proof of Mechanism/Concept, and in registrational clinical trials.
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Drive cross-functional collaboration across our data science, machine learning, lab informatics, and medicinal chemistry teams to advance our computational infrastructure for our drug discovery and development mission.
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At least 10+ years of experience in an aseptic drug product technical role in process development and/or manufacturing for biologics and/or cell therapy products, and demonstrated ability to implement industry-recognized best practices and risk-based approaches for sterility assurance and contamination control and prevention.
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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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drug development jobs in Woburn, MA
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