- Merck & Co. (Rahway, NJ)
- … compliance with relevant regulatory standards.Ensure robust technical plans, risk communication, drive technical and programs decisions through the development ... Medical Devices, Product Commercialization, Quality Management System Improvement, Regulatory Compliance , Regulatory Inspections, Social Collaboration, Strategic Leadership, Technology… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJob Description:-This role is part of our Business Technology Partner team in our Company's Research Laboratories IT, proposing ideas and innovative ... planning efforts of the DSCS (Development Sciences and Clinical Supply) Business Technology Partner team in order to build a high-performance engagement model with… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionDirector, Packaging Shipping Systems (Logistics and Distribution Technology )Reporting into the Director Packaging Distribution, Components and Systems ... COE the Director, Logistics and Distribution Technology will be responsible and accountable for subject matter expert technical support for distribution and… more
- Merck & Co. (Rahway, NJ)
- …science is applied to deliverables for new product introductions and technology transfers across the network.Drive proactive risk management activities, ... Job DescriptionReporting into the Director, Logistics and Distribution Technology the Associate Director, Logistics and Distribution Technology will be… more
- Merck & Co. (North Wales, PA)
- …packaging process and equipment issues, optimizing processes, and ensuring compliance . Effective collaboration with site-based and above-site based functional teams ... advanced skills in creating and improving business, technical, and compliance processes, and leading high-impact cross-functional teams.Responsible to lead or… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …combines deep expertise in CAR-T process technologies with a strong focus on compliance auditing, risk assessment, and continuous improvement.The Compliance ... 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)
- …GCP Guidelines, Management Process, Medical Writing, Process Improvements, Regulatory Compliance , Risk Management, Social Collaboration, Strategic Planning, ... to implement `quality by design` within clinical development programs, using a risk -based approach.The incumbent will be accountable for the overall strategy for… 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 images ... management, and continuous improvement initiatives to guarantee the robustness and compliance of our company's product portfolio across the internal and external… more
- Merck & Co. (Rahway, NJ)
- … compliance with relevant regulatory standards.Ensure robust technical plans, risk communication, drive technical and programs decisions through the development ... is a key leadership role within the Device Development and Technology Organization. This position is responsible for providing strategic leadership, technical… 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 images ... management, and continuous improvement initiatives to guarantee the robustness and compliance of our company's product portfolio across the internal and external… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of detection, evaluation, and if applicable, proposed actions (eg, changes to product information and/or other risk minimization measures) as a result of a ... 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)
- …and drug product container closure systems including mold qualification and regulatory compliance .- To act as master data stewards and support enterprise wide ... shooting and continuous improvement initiatives to guarantee the robustness and compliance of our company's product portfolio across the internal and external… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Chemical Commercialization Technology (CCT) department, which is part of the our Manufacturing Division, is seeking self-motivated individuals who ... ingredients (API) process characterization work by learning and utilizing Quality Risk Management methodologies and tools for statistical design of experiments. This… more
- Merck & Co. (Durham, NC)
- 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 ... This role will provide end-to-end support of manufacturing science and technology for commercial vaccine products including Drug Substance, Drug Product, and… more
- Merck & Co. (Durham, NC)
- 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 ... This role will provide end-to-end support of manufacturing science and technology for commercial vaccine products including Drug Substance, Drug Product, and… 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 ... optimization and provide dedicated engineering expertise related to new process/ technology integration and facility expansion initiatives.Key Responsibilities This individual's… more
- Merck & Co. (Rahway, NJ)
- …pipeline commercialization activities, process characterization, control strategy development, technology transfer to internal and external manufacturing sites, ... the design and planning phases whenever possible.Provides timely and accurate information and status updates to project sponsors and management.May be responsible… more
- Merck & Co. (Rahway, NJ)
- …will be expected to exhibit a mindset of safety and quality compliance , which will include following current Good Manufacturing Practices (cGMPs), participating in ... risk assessments, and Good Documentation Practices (GDPs).-In addition to...mechanistic understanding of impurity rejection.Documented successes of scale-up and technology transfer for small molecule crystallizations, moving from laboratory… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to interpret problems and effectively determine appropriate resolutions that ensure compliance and minimize risk .Ability to collaborate well with stakeholders, ... 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 ... experience in process modeling, scientific machine learning, deep learning, and technology deployment.Expertise in Python with hands-on experience in deep learning… more