- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking Associate Technical Lead as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe Associate Technical Lead will ... knowledge of the cell and gene therapy manufacturing process technology and maintain oversight on process capability to ensure...continuously improving. Work with the Data Management and Integration Lead and Process Validation lead on the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …team members to ensure that the organization is in a perpetual state of compliance as follows:Support the Global Quality Lead (s) (GQLs) and Regional Quality ... of people globally by leveraging our world-class science and technology . With more than 125 years of scientific expertise...the status of Quality Events (QEs), CAPAs and GCP compliance matters raised to the GQLs and/or RQLs from… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …own the process knowledge of the cell and gene therapy manufacturing process technology to support technical activities for transfers into and out of the Raritan ... would provide reduction in COGs, increase throughput, capacity and quality compliance .Provide technical expertise in the evaluation of potential process changes for… more
- Merck & Co. (Rahway, NJ)
- …device industries to set tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes.-- This position ... applicable regulatory, quality, company, and customer requirements.-This position will lead cross-functional development teams within and external to Device… 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 ... to collect information, analyze quality related process, define strategies to lead to the development and implementation of quality improvement initiatives across… 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 ... primary accountability for operational study level time, cost and quality deliverables. Lead the development of the clinical study plan including critical path… more
- Merck & Co. (Rahway, NJ)
- …and Plant) within RIPL. -As Sr. OT Infrastructure Specialist, you will lead the definition and implementation of high-level requirements, principles and models that ... services where none exists.- Recommend obsolescence programs for the technology and infrastructure wherever possible.Technical experience in building and maintaining… 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 ... including operating model, SOPs, study resource requirements, and supportive technology (as needed), for the risk-based central monitoring function.Interacts with… 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 ... areas centered around rare diseases and immune disorders. SummaryAccountable to lead , manage and ensure that all Contract Manufacturing, Testing and Warehousing… 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 ... on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either...development or approval for either the US or EU.Ensure Compliance with Core Data Sheets/Label Changes: Manages updates to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …best practices, data standards, clinical programming methods, techniques, and technology recommendations to enhance business capabilities, improve compliance ... of people globally by leveraging our world-class science and technology . With more than 125 years of scientific expertise...to manage and coach people, and the capability to lead multiple projects concurrently are crucial for this role.… 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 ... (SAP).Study Execution: Reviews patient demographics, enrollment, retention and protocol compliance for consistency with study strategy; reviews emerging clinical… 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 ... and prioritize improvement opportunities with the greatest impact.Process Optimization Lead initiatives to standardize, simplify, and optimize core processes across… 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 ... HCM Platforms and processes. This position will act as the functional lead with technical and operational expertise across multiple HRMS applications, possessing… 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 ... studies as well as programs or franchises.When sitting on a study team, lead the study team to develop a cross-functional, integrated study plan and create… 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 ... goals as identified by senior management.ResponsibilitiesActs as a brand attorney and lead legal advisor for the commercial business and operations supporting US… 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 ... listings, SAP, Data Mgmt plan; Reviews patient population and protocol compliance for consistency with study strategy; Develops biomarker strategy in collaboration… 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 ... Functions, as assigned (including but not limited to as Human Resources, Compliance , Finance and/or IT. Coordination with, and appropriate supervision of, outside… 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 ... and support materials for end-users, handling of queries, troubleshooting, and quality control. Lead or support consulting and implementation projects in the area of… more
- Tris Pharma (Monmouth Junction, NJ)
- …spanning neuroscience and other therapeutic categories employing our proprietary science and technology .Our science and technology make us unique, but it is ... This is an individual contributor role with potential to lead and manage a small team in the future....managers and other stakeholders to ensure data quality and compliance with regulatory requirementsContributes to preparation of clinical study… more
