- 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
- 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
- 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
- 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. (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
- Merck & Co. (Durham, NC)
- …Matter Experts (SMEs) and presenting to auditors as needed. Act as a validation subject matter expert in support of quality risk assessments and ... regulatory inspections. Partner with other area Validation leads to for alignment, organizational strategy, and opportunities to provide support across the areas. Deliver validation-related projects, including planning, protocol generation, execution, and… more
- Eisai, Inc (NJ)
- …Lead the development of MSL educational assets. Serve as a medical leader and subject matter expert for relevant external (HCPs, strategic alliances etc.) ... generation, and scientific communication/publications. The Medical Director will utilize expert medical/scientific knowledge in Neuroscience and Alzheimer's disease to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and routine operation of a new CAR-T manufacturing process. They will be a subject matter expert for the manufacturing process and equipment primarily ... adherence to procedures and instructions.Support compliant manufacturing investigations and CAPAs, as subject matter experts.Be a point of contact with equipment… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …initiatives implemented and support NNUS Tax Operations team on tax audits as a subject matter expert . Physical Requirements 0-10% overnight travel required. ... and leverage internal stakeholder relationships to gain business understanding and provide expert quality deliverables in the form of tax planning proposals and… 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
- Aequor (Thousand Oaks, CA)
- …multi-site impact. 8. Support of investigations and corrective actions. 9. May serve as subject matter expert to develop technical training. 10. May perform ... RM Networks including following up and resolving issues that arise. 2. Provide expert support to RM IQA network. 3. Coordinates, manages, and performs changes to… 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. (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
- 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
- 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
- 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
