- Merck & Co. (Rahway, NJ)
- …Duties and Responsibilities:Utilize extensive experience in design controls, device transfer, control strategies, device risk management , and design ... technology transfer programs in both development and lifecycle management , ensuring compliance with relevant regulatory standards.Ensure robust technical plans, … 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
- 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
- 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...all DS regions. The Associate Director of the Signal Management Center of Excellence (CoE) will lead the daily… 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 ... blisters) meet safety, efficacy, quality, and robust supply standards. Drive proactive risk management activities, including risk assessment, risk… more
- Merck & Co. (Rahway, NJ)
- …new products.Technical Expertise: Utilize extensive experience in design controls, device transfer, control strategies device risk management , and design ... technology transfer programs in both development and lifecycle management , ensuring compliance with relevant regulatory standards.Ensure robust technical plans, … more
- Merck & Co. (Rahway, NJ)
- …of GCP/ICH and worldwide Regulatory Health Authority requirements.Has delivered effective CAPA management solutions.Has worked with risk management tools and ... Management Process, Medical Writing, Process Improvements, Regulatory Compliance, Risk Management , Social Collaboration, Strategic Planning, Strategic… 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 ... exploring alternative ways to view and solve problems to achieve results. Drive proactive risk management activities, including risk assessment, risk … more
- Merck & Co. (Durham, NC)
- …pharmaceutical industry technical business processes including:- technical documentation, change control , portfolio management , risk mitigation, deviation ... 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. (Durham, NC)
- …pharmaceutical industry technical business processes such as:- technical documentntation, change control , portfolio management , risk mitigation, deviation ... 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)
- … skillsAbility to effectively identify and express risks Preferred Deviation management and change control processesAuthoring and/or reviewing technical ... Assays, Cell-Based Assays, Chromatographic Techniques, GMP Environments, Innovative Thinking, Management Process, Process Analytical Technology (PAT), Ultra… more
- Merck & Co. (Rahway, NJ)
- …guidance) including various pipeline commercialization activities, process characterization, control strategy development, technology transfer to internal ... of the following: process characterization (PC), process performance qualification (PPQ), risk assessment (RA), control strategy, process comparability reports,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to IQ/OQ/PQ, EMPQ, APS, PPQ, preferred.Experience with change management /change control and quality systems.Experience with FMEA and risk assessment ... 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
- Merck & Co. (Rahway, NJ)
- …include following current Good Manufacturing Practices (cGMPs), participating in risk assessments, and Good Documentation Practices (GDPs).-In addition to supporting ... develop crystallizations for first GMP deliveries.Experience with developing crystallizations to control and optimize the purity profile of API and intermediates by… 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, ... 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to drug product manufacturing required to deliver time, cost, quality, and risk management to teams.Experience with Healthy Authority requirements and regulatory ... 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
- Merck & Co. (Rahway, NJ)
- …experiment design; applying physics-based and hybrid models to guide and de- risk scale-up/scale-down during technology transfer and commercialization; developing ... technology adoption frameworks, including a successful track record of technology change management .Current Employees apply HERE Current Contingent Workers… 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)
- …Machines, Plastic Injection Moulding, Product Lifecycle, Prototyping, Reaction Injection Molding, Risk Management , Self Motivation, Statistical Analysis {+ 1 ... and AssemblyThis position is in our organization's Device Development & Technology (DD&T) group in our Research division.- Our organization's DD&T group… more
- NorthMark Strategies (New York, NY)
- …This role will support the development and execution of best-in-class insurance and risk management strategies across the organization, with a focus on Owner ... and alternative risk transfer strategies. Requirements: Bachelor's degree in risk management , Insurance, Finance, Business Administration, or a related… more
