- Genmab (NJ)
- …and integrity of external data across the clinical trial portfolio. This role serves as a Subject Matter Expert ( SME ) in protocol quality, central and ... submission goals.Participate in governance forums and asset-level data planning initiatives. Subject Matter ExpertiseProvide protocol-level consultation and design… more
- Merck & Co. (Durham, NC)
- …to improve the execution/review process for equipment.Develop training material. Working as a subject matter expert ( SME ), provide necessary training ... all utility systems regarding functionally of equipment and relied on as SME during regulatory discussions for HVAC/R. PROBLEM SOLVING: Identifies and resolves… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and TFLs.Responsibilities:- Supporting project lead on outsourced projects, act as statistical programming subject matter expert ( SME ) to support ... enhance the system, develop system training materials and work as the SME to support implementation, evaluate, request and approve system upgrades, and… more
- Merck & Co. (Rahway, NJ)
- …them to pipeline assetsCollaborates effectively within and across functional areas and is a recognized subject matter expert in at least one area of drug ... individuals in a peer-to-peer fashion and as a technical mentorRecognized as a subject matter expert in at least one drug delivery and/or manufacturing… more
- Merck & Co. (Rahway, NJ)
- …functional areas to lead the development of novel drug delivery technologies - Is a recognized subject matter expert in at least one area of drug delivery ... mentoring capabilities to build individuals and teams - Recognized as a subject matter expert in multiple drug delivery and/or manufacturing technology -… more
- Novo Nordisk Inc. (WA)
- …intellectual property. Manages relationships with select government agencies. Serves as a subject matter expert . Solicits internal stakeholder insights to ... to NNI. Essential Functions Achieve deep understanding of, and serve as a subject matter expert on, assigned policy areas and the potential impact to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …clinical trials meets quality requirements and best practices. This position serves as a subject matter expert for laboratory data and management of ... data management deliverables at the department level.- Serves as a Subject Matter Expert on laboratory data, technology usage, and disease-specific… more
- Merck & Co. (Durham, NC)
- …uptime, minimizing cost and maintaining process consistencyDevelop training material. Working as a subject matter expert ( SME ), provide necessary ... training for system maintenanceWork alongside operations and lean six sigma team members to develop reliable, consistent manufacturing processes that meet cGMP requirementsSupport safety programs (LOTO, HECP, etc.) and environmental compliance from a… more
- Merck & Co. (Durham, NC)
- …uptime, minimizing cost and maintaining process consistency.Develop training material. Working as a subject matter expert ( SME ), provide necessary ... training for system maintenance.Work alongside operations and lean six sigma team members to develop reliable, consistent manufacturing processes that meet cGMP requirements.Support safety programs (LOTO, HECP, etc.) and environmental compliance from a… more
- Repligen (Waltham, MA)
- …aptitude and an exceptional problem-solving ability are important. Responsibilities Serve as a Subject Matter Expert ( SME ) for multiple bioprocessing ... manufacturing processes Implement new product processes in Manufacturing during the transfer from Product Development Contribute to the process design for new products during the development phase Complete IQ/OQ/PQ's on equipment and processes as needed… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Manager. Essential Functions Serves system administrator for the CMMS system and develops as Subject Matter Expert ( SME ) for CMMS related activities ... and projects Primary daily interface with the CMMS and customers to ensure workflow of calibration and maintenance work orders Responsible for supporting troubleshooting and providing support to plant staff related to workflow issues within the CMMS Generate… more
- Cytiva (Muskegon, MI)
- …Business System which makes everything possible.The Quality Assurance Engineer will be the subject matter expert for the validation strategy and maintain ... process improvements related to equipment qualification and validation activities.Be the subject matter expert for Change Control on launched products,… more
- Cytiva (Miami, FL)
- …(direct flow filtration, tangential flow filtration) and in-depth knowledge of filtration products.Be subject matter expert who stays abreast of developments ... yourself and us - working on challenges that truly matter with people that care for each other, our...through training, advising, and hands-on project support.Be a technical SME at key customer meetings and provide technical leadership… more
- Raytheon (Huntsville, AL)
- …Raytheon and Missile Defense Agency (MDA) stakeholders and other organizations.Ability to become Subject Matter Expert ( SME ) on development ... capabilities.Qualifications You Must Have:A minimum of a Bachelor's Degree in Science, Technology, Engineering, or Mathematics (STEM) and 5 years of prior relevant experience.Experience developing object-oriented software using C++.Experience with Modeling and… more
- Raytheon (Huntsville, AL)
- …issuesInvestigate root-cause failuresReview and modify subsystem requirements and test plansAct as a subject matter expert ( SME ), preparing and ... presenting to peers, administration, and government customersWork within a multi-disciplined team including electronics hardware, software, firmware, mechanical, systems, test, supply chain, etc.Collaboration with both Functional and Program higher level… more
- Merck & Co. (Rahway, NJ)
- …and processes. Handle small projects as a lead analyst, project manager, or as the subject matter expert . Account and manage for the demands per region ... partner with the business via managing specific Order to cash process area or subject eg Order management, Customer Master. Based on our SAP template and the… more
- Merck & Co. (Rahway, NJ)
- …quality.Ensure compliance with all regulatory requirements and quality standards, serving as a subject matter expert in the medical device and pharmaceutical ... and research and manufacturing sites.-Building and hiring talent, developing team's subject matter expertise, and strengthening leadership influence while… more
- Aequor (Seattle, WA)
- …necessary technical analysis to support impact assessments and investigations.Function as a subject matter expert for autologous T-cell therapies and ... manufacturing technologies.Provide technical input and requirements for design of future clinical and commercial manufacturing facilities.Present complex technical topics internally and externally.Share operational and process leanings with the rest of the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …process platform improvements and cost reduction initiativesServe as a technical leader and subject matter expert during regulatory engagements (FDA, EMA) on ... manufacturing innovation topics.Foster a culture of innovation, data-driven decision-making, and proactive problem-solving across Global MSAT.Stay informed on industry trends, emerging technologies, and competitive landscape in cell and gene therapy… more
- Merck & Co. (Rahway, NJ)
- …extensive partnership with manufacturing sites and global GMP SMEs.Key FunctionsServe as a subject matter expert for good manufacturing practices for drug ... products, active-pharmaceutical ingredients, biologics, vaccines, and devicesEnsure that global QMS documents meet major health authority GMP requirements-Provide consulting and research services to global QMS topic owners and site quality experts to assess… more
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