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Experience in engaging regulatory professionals for navigating the product development process through FDA regulatory submission, scaling manufacturing, and post market surveillance. This is an opportunity to join a dynamic team as an Engineer I, Medical Device at a venture backed Medical Device organization, reporting directly to the CTO. The successful candidate will drive key activities throughout the development phases of the combination product as well as transitioning the design to large-volume manufacturing, and facilitate the deliverables to support regulatory filing, product launch, and post market surveillance.
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DE performing full stack development in an Information Technology (IT) product development organization, and Amazon Web Services (AWS) environment, using TypeScript, Node.js, Java, API development, Spring Boot, Apache Tomcat, and RDBMS; and analyzing, designing, developing, and testing scalable Cloud based software applications.
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You’ll work closely with other departments such as Product Operations, Fraud, CX, Compliance, and the broader VIP organization to design, execute, and operate these products, while managing a team of specialized VIP hosts to service and support all our peer-to-peer customer focused products.
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Leads and collaborates in the development of post-approval global CMC regulatory strategies for an approved cell and gene therapy product. The Director, Regulatory CMC (Chemistry Manufacturing Controls) is responsible for the development and implementation of post-approval global regulatory CMC strategies for a marketed cell and gene therapy product.
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In reality, this means working with the leaders of the following groups – AI Research, Engineering, Product, Computational Chemistry, Medicinal Chemistry, Biology, Business Development, and Operations – to ensure t.
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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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Research Product Manager for RNA Assays and Products. Cultivate and drive improvements to the Tempus assay development process. As an individual contributor, manage a cross-functional team of scientists, engineers, and others to drive the planning, design, and development builds of our RNA portfolio that facilitate clinical decision support.
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You will be part of a cross-functional Product Development team advancing our novel technology into a regulated lab environment to deliver new clinical insights to physicians and their patients.
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The person will work directly with stakeholders across - ESG Investments, ESG Product Strategy, ESG Data and Operations, Client, Product and Regulatory Reporting, and Enterprise Risk Management to understand their data and reporting requirements and to translate requirements into functional specifications for technology partners building/ enhancing IT solutions for ESG reporting.
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This role will enhance development operations processes; oversee the donor database; manage data entry and gift processing, acknowledgements, and report generation; support donor research, communications, outreach, and fundraising campaigns; assist with special events; and provide critical administrative support as the “glue” of the development team.
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Experience in power electronics product development - design concept, prototyping, product validation testing, launch, and product life cycle suppor. Work with development partners/peers to perform failure analysis and corrective actions.
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The position will be part of an integrated R&D team that aims to advance preclinical gene editing candidates into the clinic and work closely with discovery and process development groups. Verve is seeking a Scientist/Sr Scientist within the Analytical Research and Development team, to develop and implement biophysical and separation methods and technologies to characterize mRNA, gRNA and LNP-encapsulated gRNA and mRNA. This individual will be interfacing with a cross-functional team to design, develop and support phase- appropriate analytical methods to enable Verve’s growing gene editing pipeline.
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Create launch plans for new product(s) or service(s) in partnership with Product and Business Development teams including target customer identification, key messages, go-to-market plan, and market growth pathways.
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The Commercial Counsel, will serve as lead commercial counsel supporting apraglutide, Ironwood’s product candidate in Phase 3 development for the potential treatment of rare gastrointestinal (GI) diseases, including short bowel syndrome with intestinal failure and acute graft-versus-host disease.
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We’re looking for an experienced Lead Product / UX Designer to apply their knowledge and expertise in user research, design processes, and UX best practices to the development of first-class platforms and applications that are defining the digital advertising industry.
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product development jobs Title: customer success manager in Boston, Bolingbrook, Illinois
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