- Merck & Co. (North Wales, PA)
- …teams.Responsible to lead or support-complex technical projects and/or equipment technology assessments within the packaging and Medical Devices & Combination ... transfer/relocation, device component source change assessment, and packaging site operational & launch support.- This will include approximately 30% travel… more
- Merck & Co. (Rahway, NJ)
- …associates, promoting knowledge sharing, skill development, and adherence to operational discipline.Collaborate with cross-functional teams to support technology ... Director will collaborate cross-functionally to drive scientific innovation and operational excellence, ensuring robust, scalable, and compliant microbial fermentation… more
- Merck & Co. (Rahway, NJ)
- …and Head of CQO, the CQOM is accountable for the execution of operational quality activities within the assigned therapeutic area.- This includes operational ... 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
- Eisai, Inc (Nutley, NJ)
- …the department's transition to data-driven issue identification and mitigation, leveraging technology and analytics to enhance operational efficiency. The role ... reviews of commercial call logs and HCP payment records Serve as the operational lead for Eisai US's Compliance Monitoring Program, managing internal resources and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …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 ... operations staff to ensure the effective and efficient execution of operational aspects of clinical study planning, implementation, data delivery and reporting.… 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
- 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. (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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …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 ... skills in continuous improvement, project management, change management, and risk management. Responsibilities Leadership, Direction, and Strategy: - In… more
- Merck & Co. (Rahway, NJ)
- …Services primary purpose is to provide value-added independent and risk -based audit and assurance services.Position Overview / Function and ResponsibilityUnder ... ("AIC"), the Senior Specialist will:Participate in the execution of financial, operational , SOX 404 and IT audits, integrated audits and process audits,… 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 ... building a high-performing global sourcing organizationAssess and periodically update risk scores for BOM and other high- risk materials.Co-develop… 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 ... CAR-T process technologies with a strong focus on compliance auditing, risk assessment, and continuous improvement.The Compliance Auditor will conduct internal… 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 ... site's Strategic Initiatives Team.Defines the interdependent deliverables and ensures that quality, risk , cost, time are managed within the overall approved plan to… 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 Raritan, NJ. Role OverviewThis position will be responsible for providing operational excellence project management support to the cGMP Clinical and Commercial… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …planning. Risk Management: Ability to identify, assess, and mitigate operational and compliance risks. Technology & Automation: Familiarity with modern ... developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor...the fast pace of change, balancing day to day operational demands with the need to extend and improve… more
- Merck & Co. (Rahway, NJ)
- …short-term objectives.Identifies and resolves standard day to day quality, technical, and operational problems within own unit.- Makes decisions - guided by policies ... monitoring.Ability to develop and lead others.Ability to be flexible and understand risk .Collaboration: Able to communicate clearly with team and work closely with… more
- Formation Bio (New York, NY)
- …patients, Formation Bio, founded in 2016 as TrialSpark Inc., has built technology platforms, processes, and capabilities to accelerate all aspects of drug ... the following links: Our Vision for AI in Pharma Our Current Drug Portfolio Our Technology & Platform At Formation Bio, our values are the driving force behind our… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …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 ... with Medical Affairs to facilitate the implementation of a risk -based quality management process fully embedded through trial design,...to assign tasks to remove those gaps. - Provide operational QA leadership and Quality Oversight for the Quality… more
- Monster (Mclean, VA)
- … Management (SRM) Assessor Job Description: Analyze and assess risks (including technology , privacy security, resiliency, and other operational risks) that the ... Genesis10 is seeking a Senior Risk Business Analyst for a contract position with...and will communicate escalations to management as needed. Direct risk management experience is preferred, but demonstrable transferable skills… more
