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This individual will play a crucial role in driving the discovery, selection, validation, and clinical application of biomarker and CDx assays, working closely with cross-functional product development teams to advance our pipeline and deliver breakthrough therapies to patients in need.
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The position is responsible for product development, technology transfer and overall management of CMC activities related to ensuring robust development and reliable GMP supply of oligonucleotide conjugates and intermediates.
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We are seeking a highly motivated and experienced Product Manager to lead the development and commercialization of our computational chemistry software products. Preferred Qualifications: In-depth knowledge of Scrum and Agile Software Development MethodologyExperience delivering finely-tuned product marketing strategies, digital marketing campaigns.
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Desired Qualifications: B.S or M.S. Degree in Civil Engineering Licensed Professional Engineer (PE), or (EIT) 3+ years of demonstrated engineering design of Land Development Projects Utility Design Site Grading Storm Water Management Systems Zoning Research Permitting Research Proficiency with AutoCAD, Civil 3D software Salary and Benefits: Comprehensive Salary Package.
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Strong knowledge of pharmacokinetics and pharmacodynamics principles, immunogenicity, modeling and simulation, Model-Informed Drug Development, ADME Concepts, and regulatory clinical pharmacology requirements to support clinical development and regulatory submission.
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Expertise in primary human cell culture, multi-color flow cytometry, multiplex cytokine detection, functional immune cell assays (proliferation, cytotoxicity, chemotaxis) and assay development is essential.
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He/She will evaluate and perform PCBA component level failure analysis of released product failures and, at times, customer returns; it requires rapid response to production defects and the development, documentation and implementation of corrective measures.
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Development experience ideally including previous roles within pharmaceutical and/or vaccines product development. Ensures all appropriate CMC regulatory aspects for clinical trials/product release are in place, to avoid clinical holds and/or to ensure continuity of market supply.
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Initiates and manages the complaint file, maintains accurate entry of complaints in the database, communicates to field representatives regarding information needed specific to product complaints (e.
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The Humanitarian Assistance & Disaster Relief Systems Group develops, adapts, and deploys advanced technologies to address the most significant challenges in humanitarian assistance, disaster relief, global development, community resilience, and climate change.
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Interface with market management and business unit management, divisional application development, technical and platform product management, Central Research and Development (R&D), sales and operations.
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Representing Precision Medicine at Medicine Development Teams (MDT) and/or Clinical Matrix Teams (CMT) establishing clear biomarker driven decision-making criteria to enable clinical development.
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We are looking for an experienced and highly motivated Senior Scientist to join our Reagent Research & Development team, in roles focused on driving expansion of our Single Molecule Array (Simoa) assay portfolio though development and continuous improvement of immunoassay reagent kits.
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Partnering with the Product Marketing Leader to contribute to the development of an all-encompassing product marketing strategy for Panametrics and the entire Precision Sensors and Instrumentation business.
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You will support product development as Pharmacometrics Leader by defining the dose-concentration-pharmacological effect relationships of drugs using modeling and simulation methodologies from data acquired at various stages of drug research and development.
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product development jobs Company: Trs Healthcare in Concord, MA
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