- Merck & Co. (Rahway, NJ)
- …extensive experience in design controls, device transfer, control strategies, device risk management , and design verification testing to develop value-added ... Job DescriptionJob Summary: -The Associate Director of Device Technology is a...technology transfer programs in both development and lifecycle management , ensuring compliance with relevant regulatory standards.Ensure robust technical… more
- Merck & Co. (Rahway, NJ)
- …for new product introductions and technology transfers across the network.Drive proactive risk management activities, including risk assessment, risk ... of commercialized products for the benefit of patients. The Logistics and Distribution Technology Director is integral to this mission. The successful candidate… more
- Merck & Co. (Rahway, NJ)
- …of commercialized products for the benefit of patients. The Logistics and Distribution Technology Director is integral to this mission. The successful candidate ... drug product, finished goods including combination products, and samples. Drive proactive risk management activities, including risk assessment, risk… more
- Merck & Co. (North Wales, PA)
- …tasks.Extensive experience with quantitative decision tools for root cause analysis, risk management and options analysis.Exhibited leadership qualities such as ... Equipment, Packaging Processes, Pharmaceutical Packaging, Process Optimization, Regulatory Requirements, Risk Management , Root Cause Analysis (RCA), Technical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …signal, epidemiological data, and regulatory requirement synthesize into a coherent risk management strategy.Represents the CSPV department as subject matter ... of people globally by leveraging our world-class science and technology . With more than 125 years of scientific expertise...cover signal activity across all DS regions. The Associate Director of the Signal Management Center of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …has advanced skills in continuous improvement, project management , change management , and risk management . Responsibilities Leadership, Direction, and ... around rare diseases and immune disorders. Summary The Executive Director , Data Management (Head of Global Data...work.- Proactively identifies and manages risks for the data management function and supports functional risk identification/… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …access programs.Partner with Medical Affairs to facilitate the implementation of a risk -based quality management process fully embedded through trial design, ... of people globally by leveraging our world-class science and technology . With more than 125 years of scientific expertise...and immune disorders. Job Summary: Reporting to the Sr. Director , Medical Affairs QA, the Director of… more
- Merck & Co. (Rahway, NJ)
- …extensive experience in design controls, device transfer, control strategies device risk management , and design verification testing to develop value-added ... technology transfer programs in both development and lifecycle management , ensuring compliance with relevant regulatory standards.Ensure robust technical plans, … more
- Merck & Co. (Durham, NC)
- …technical business processes including:- technical documentation, change control, portfolio management , risk mitigation, deviation management , technical ... Job DescriptionVaccines tech product leadership (V-TPL) within large molecule science and technology (LMS&T) is seeking a highly motivated individual for the role of… more
- Merck & Co. (Rahway, NJ)
- …and/or distribution and logistics of finished goods images, encompassing proactive risk management strategies, platform standards for standard finished goods ... Job DescriptionDir, Engineering - Director , Assembly and Packaging Platform Technical LeadershipReporting into...safety, efficacy, quality, and robust supply standards. Drive proactive risk management activities, including risk … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …art presentation skills, power point, Visio, budget, resources, algorithms, projections, risk management and mitigation. Operational Oversight and Reporting: ... unmet medical needs of people globally by leveraging our world-class science and technology . With more than 125 years of scientific expertise and a presence in… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Safety MD, will lead the development and implementation of integrated project/product risk management strategies aimed at achieving the optimum benefit- risk ... but also expert advisory) interactions to ensure quality outcomes in the risk evaluation and management of assigned projects/products.Define and implement… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study teamsDevelop best practices and lessons learned mechanisms within Clinical OperationsDevelop risk assessment & risk management and clinical project ... unmet medical needs of people globally by leveraging our world-class science and technology . With more than 125 years of scientific expertise and a presence in… more
- Merck & Co. (Rahway, NJ)
- …(NGB) facility at our company Rahway, NJ site. By integrating leading-edge technology with a dynamic, activity-based workspace, the facility will support seamless ... administrative processes.Support the development of GMP Documentation such as:- Risk Assessments, Batch Records, Sampling Plans, Qualification Documents, and… more
- Merck & Co. (Rahway, NJ)
- … Management , Pharmaceutical Process Development, Process Scale Up, Program Risk Management , Project Planning, Protein Characterization {+ 2 more}-Preferred ... pipeline programs using fed-batch and continuous manufacturing platforms. The Director , Biologics Process Development (BPD) within the Biologics Process Research… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Strong financial acumen with experience managing budgets, forecasts, and headcount planning. Risk Management : Ability to identify, assess, and mitigate ... we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell ... in the treatment of multiple myeloma.Legend Biotech is seeking Director of Manufacturing Execution System as part of the...System (MES) will be part of Manufacturing Science and Technology (MSAT) Leadership Team and will be responsible for… more
- Merck & Co. (Rahway, NJ)
- …and inspire accountabilityEthical, resilient, and committed to excellenceSkilled in risk management , team facilitation, and strategic planningExperience in ... documentation of all stages of cell culture process commercialization. Risk assessment, control strategies, process comparability reports, Process performance… more
- Formation Bio (New York, NY)
- …CMOs, software vendors, and other biotech service providers. Knowledge of contract law, risk management , and compliance in vendor agreements. Ability to work ... patients, Formation Bio, founded in 2016 as TrialSpark Inc., has built technology platforms, processes, and capabilities to accelerate all aspects of drug… more