- Merck & Co. (Rahway, NJ)
- …& Process Development (DPPD) Team within our Device Development & Technology (DD&T) organization designs, develops, and commercializes novel biologic/ drug/ vaccine ... experts within the broader DD&T team (eg design verification, device risk management, human factors, technical integration, assembly automation, etc.), as well… 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)
- …space, including process flow diagrams & engineering drawingsProcess development and technology transfer experience including the use of risk assessment ... as well as advancing a culture of scientific excellence, GMP and compliance mindset and collaboration with various partners and stakeholders in development.The… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …identified during internal systems audits, remediations implemented and CAPAs pending.Support Risk Mitigation programs to ensure compliance to regulatory ... of people globally by leveraging our world-class science and technology . With more than 125 years of scientific expertise...in alignment with the Master Audit Schedule using a risk -based approach to ensure the Audit Plans are aligned… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Chemical Commercialization Technology (CCT) department, which is part of our Manufacturing Division , is seeking self-motivated individuals who ... develop safe and robust manufacturing processes through process characterization, technology transfer, validation, filing and supply support of late-stage projects… more
- Merck & Co. (Rahway, NJ)
- …within Device Development and with external suppliers.Understand and apply regulatory / compliance requirements relative to design controls and risk management ... Design Controls(Associate Director Equivalent) Our company's Device Development & Technology (DD&T) Team designs, develops, and commercializes novel biologic/drug/vaccine… more
- Merck & Co. (Durham, NC)
- …Lead Periodic Business and Operations Review Meetings (with External Partner).-- Compliance :-Achieve compliance goals through a risk -based approach ... Risk Mitigation:-Ensure External Partner Site Readiness, Assist with Technology Transfer, Develop and Execute Manufacturing Process Robustness Plans, Production… more
- Merck & Co. (Rahway, NJ)
- …of manufacturing GMP steps, demonstration of new manufacturing technology /processes, training opportunities for improved manufacturing process development, and ... seamless technology transfer to commercial sites.The SSO Operations Specialist will...hands on assistance for daily production activities while ensuring compliance with Safety & Environmental (S&E) and current Good… more
- Merck & Co. (San Francisco, CA)
- …ensure successful implementation of project plans.- Escalates issues through the risk log and drives problem-solving and resolution within the team.Operating Model ... development or manufacturing, including process or analytical development, characterization, technology transfer, validation/PPQ, commercial manufacturing, and process and plant… more
- Merck & Co. (Rahway, NJ)
- …Inventors. Through innovative thinking, state-of-the-art facilities, cutting-edge science, and technology , we collaborate to deliver the next medical breakthroughs. ... investments in continuous manufacturing, green and sustainable processes, and proprietary technology platforms. We actively publish and engage with the scientific… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … Management: Ability to identify, assess, and mitigate operational and compliance risks. Technology & Automation: Familiarity with modern manufacturing systems ... 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
- Novo Nordisk Inc. (Durham, NC)
- …operate within compliance with a quality mindset that focuses on risk management & mitigation Lead the training & implementation of effective change management ... assignments within compliance with a Quality Mindset that focuses on risk management and mitigation. Utilize the appropriate cLEAN® tools when relevant Lead in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …unmet medical needs of people globally by leveraging our world-class science and technology . With more than 100 years of scientific expertise and a presence in ... around rare diseases and immune disorders. SummaryThe Manager Audits & Compliance , GCP/Document Audits supports end-to-end audit activities per audit program of… more
- Merck & Co. (Rahway, NJ)
- …(BPR&D) organization is responsible for designing and implementing novel bioprocess technology platforms and processes for upstream and downstream processes that ... network internally and will advance a culture of scientific excellence and compliance with our company's procedures for recording time, data entry, and trainings.… 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 ... will be responsible for reviewing and approving qualification protocols, reports, risk assessments, technical studies, and any associated documentation in support of… 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 ... Out of Tolerance (OOT) situations and other technical documentationConducts basic risk mitigation options and advanced troubleshooting to identify root cause and… more
- Merck & Co. (Rahway, NJ)
- …business objectives. Provide technical guidance during projects, assess viability of technology in proposed configuration, verify adherence to company standards and ... Management, And Incident InvestigationsFacilitating Process Hazard Analysis and Execution of EHS Risk Assessments.Must Have At Least 2 Years of Experience in The… 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 evaluation of potential process changes for effectiveness, value, risk , and priority.Drive the implementation of MES enhancements that would provide… more
- Toyota (Plano, TX)
- …change. You will be instrumental in fostering strong partnerships across Information Technology , Data, Risk , Legal, and Compliance functions to promote a ... **Senior Analyst, Risk Management** to join the Technology Compliance team. This role is ideal...auditing. + Strong understanding of IT domains such as Information Security, IT Governance, Operations, Data Management, Application Controls,… more
- Lincoln Financial (Salem, OR)
- …documentation and communications for all assessments in Lincoln's online information technology (IT) governance, risk , and compliance platform. + ... respond to requests from external parties concerning Lincoln's own information risk management practices. **What you'll be...+ Work arrangements that work for you + Effective productivity/ technology tools and training The pay range for this… more
