- Merck & Co. (Rahway, NJ)
- …Pharmaceutical Sciences, Process Leadership, Product Management , Rapid Prototyping, Risk Management Framework, Scientific Data Management , ... and Development Sciences (RaDS) value team in our Company's R&D IT brings together product management , engineering, and data science expertise. We enable … more
- Merck & Co. (Rahway, NJ)
- …etc.Material characterization and failure mode analysis and integration with combination product risk management .Stress-strain testing of different materials ... development, such as manufacturing process development and validation, design control, risk management , material and molding, design validation to create and… more
- Merck & Co. (Rahway, NJ)
- …exploring alternative ways to view and solve problems to achieve results Drive proactive risk management activities, including risk assessment, risk ... thermal and distribution qualification for pharmaceutical products.Strong understanding of risk management principles.Strong strategic and analytical thinking,… more
- Merck & Co. (Rahway, NJ)
- …Database Management , Data Integration, Detail-Oriented, IT Infrastructure Management , Marketing, Procurement, Product Lifecycle, Product ... seeking an experienced professional with a strong background in Product Management to shape the vision and...standards, partnering with compliance and quality teams as needed. Risk & Issue Management Capture and manage… more
- Merck & Co. (Rahway, NJ)
- … Process, Managing Engineering Teams, Operational Metrics, Performance Monitoring, Project Management , Research Databases, Risk Management , Status Reporting, ... Experience in one or more of the areas of Drug Substance development, Drug Product development, Clinical Supply management or Analytical Research is critical for… more
- Merck & Co. (Rahway, NJ)
- …framework with all levels of management .Must have strong understanding of product management systems and tools, strong business and financial skills, ability ... Process, Manufacturing Scale-Up, Process Improvements, Product Commercialization, Product Lifecycle, Product Management , Regulatory Requirements,… more
- Merck & Co. (Rahway, NJ)
- …drug product , finished goods including combination products, and samples. Drive proactive risk management activities, including risk assessment, risk ... and external stakeholders. Required Skills: Biopharmaceutics, Biopharmaceutics, Business, Change Management , Combination Products, Compliance Packaging, Cross-Cultural Awareness, Data… more
- Merck & Co. (Rahway, NJ)
- …for new product introductions and technology transfers across the network.Drive proactive risk management activities, including risk assessment, risk ... Process, Manufacturing Scale-Up, Mentorship, Packaging Engineering, Process Optimization, Risk Management , Root Cause Analysis (RCA), Social Collaboration,… more
- Merck & Co. (Rahway, NJ)
- …NJ, Formulation, Laboratory, and Experimentation (FLEx) Center to support drug product development and GMP clinical supply of sterile dosage forms.- Positions ... and knowledge capture of processes, which could include providing feedback on product and process development.These roles require adherence to GMP procedures, strong… more
- Merck & Co. (Rahway, NJ)
- … Management , Customer Experience Management , Management Process, Management System Development, Product Management , Requirements Management , ... with privacy, consent, and targeting frameworksEnsures cross-functional consistency with tech, data , and risk /legal functions on experience and regulatory… more
- Merck & Co. (Rahway, NJ)
- …and Policy, Licensing and Evaluation (PEL).Develop and maintain global Quality Management System (QMS) documents pertaining to USDA requirements for facility design, ... and ensure team and company adherence to these documents.Develop a risk -based approach to prioritize USDA compliance requirements for our manufacturing… more
- Merck & Co. (Rahway, NJ)
- …executing analytical methods to release clinical drug substance and drug product and support both non-sterile and sterile manufacturing.- This role contributes ... a state of inspection readiness. Performs proactive resourcing planning and risk assessment strategies. Advances a culture of scientific excellence, GMP compliance… more
- Formation Bio (New York, NY)
- …carried out efficiently and effectively. Ensure the appropriate identification, evaluation, and management of risks associated with product quality. Build strong ... regulatory requirements, including GMP, GCP, and ICH guidelines. Expertise in Quality Management Systems (QMS). Extensive knowledge of quality risk assessment… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …epidemiological data , and regulatory requirement synthesize into a coherent risk management strategy.Represents the CSPV department as subject matter expert ... all DS regions. The Associate Director of the Signal Management Center of Excellence (CoE) will lead the daily...evaluation, and if applicable, proposed actions (eg, changes to product information and/or other risk minimization measures)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Director, Clinical Safety MD, will lead the development and implementation of integrated project/ product risk management strategies aimed at achieving the ... but also expert advisory) interactions to ensure quality outcomes in the risk evaluation and management of assigned projects/products.Define and implement… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of events that occur in the production of a personalized cell therapy product in a sterile GMP environment. The ideal candidate for this role demonstrates ... Actions (CAPA's) are developed and implemented.Escalation of events to management that potentially represent significant quality issues or issues resulting… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …be responsible in handling day-to-day activities inclusive of execution, protocol management , vendor management , issues, deviations, corrections and remediation ... program to enable robust production, testing and release of product to patients.Key Responsibilities Executes the commissioning, qualification, requalification,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …cell therapy product in the Multiple Myeloma space including validation, data analytics and commercial support. The Quality Compliance scope includes working on ... for evaluation of changes to the same and their impact on the Carvykti product . Stakeholder management is required to drive and implement documentation template… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …tracking of quality metrics while ensuring high quality and complaint product supply.Key Responsibilities Support compliance activities for site Quality Operations ... within facility.Perform internal housekeeping audits.Perform analysis on quality indicating data and identifying trends.Provide oversight for trending of quality… more
- JPMorgan Chase (New York, NY)
- …to senior management and other stakeholders + Proven experience in risk management , data analytics, product development or a related field within a ... This role will allow you to promote innovation in risk management , product development, and...data and analytical frameworks to support the bank's risk management strategies, with a focus on… more
