- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …documentation.Vendor Management -supports Person in Plant (PIP) activities when packaging operations for DSI are in- process . Supports investigational product ... with CSO project Management LeadResponsible for the Clinical Label Development process which includes creation of master label text, translations, and label… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(IQ/OQ/PQ), Test Scripts and Summary Reports.Support the change management process for validated systems where necessary.Maintain effective communication ... DX Computer System Validation (CSV) projects within Daiichi Sankyo, for Computerized Systems supporting GxP and Non-GxP activities, assuring that these systems … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of concern and either resolve, propose solutions, or bring to the attention of the operations lead of study team lead . Coordinate and liaise with Daiichi ... involve ICF, CRF guidelines, IB and safety communications, DSUR, IND. Lead the CRO and vendor selection process ...performance and quality metrics and share with study team, Operations Program Lead , and Sr. Director for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …flow of documents in order to meet submission timelines. The Director will develop the process , tools and systems needed to build a core dossier for global ... and immune disorders.Summary The Director, Head of Global Dossier Planning, Regulatory Operations is responsible for leading the dossier planning team and leading… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking an Operations Process Trainer (2nd shift) as part of the Technical Operations ... team based in Raritan, NJ. Role Overview Operations Process Trainer will be responsible for performing process training activities for Operations team… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking Quality Systems Lead role as part of the Quality Operations team based in Raritan, New ... Jersey. Role Overview The Quality Systems Lead role is an exempt level...GMP environment. This role will serve as the business process owner for the Corrective and Preventive Actions (CAPA)… more
- Insmed Incorporated (Bridgewater, NJ)
- …Chemistry) will have responsibility for the management of API/Intermediate/RSM manufacturing operations at Insmed's CMOs including tech transfer, process ... the Technical Operations liaison to the Insmed research team for lead optimization and early development programs. This position will be the dynamic… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Key Responsibilities Lead and supervise multiple units within the CAR-T process operations (ie component preparation manufacturing, MFG support operations ... standard operating procedures and batch records and ensure safe and compliant manufacturing operations according to cGMP requirements. Lead the daily start of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to meet global demand and commercial forecasts Drives and prioritizes operations improvement (closed process , streamlined operations ) implementation, ... myeloma. Legend Biotech is seeking Associate Director, Global Strategic Operations & Capacity Planning Head as part of the...be responsible for a global operational strategy and investigations lead / owner for a best-in-class high volume marketed… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Global review, tracking of milestones as per contract). Ensure the global clinical operations systems for management of company sponsored studies review and ... diseases and immune disorders. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in the execution of all Global… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of 5 years' experience in pharmaceutical or biotechnology across clinical trial operations . Experience in training, process improvement, and project management ... with process mapping tools (eg, Visio, Power Point), training systems , and metrics dashboarding preferred- Understanding of industry trends (eg, regulatory,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to meet GRA needs and enable visibility across regions and sub-functionsPartner with the Process Excellence Lead and others to identify process improvements ... will be a key member of the Global Regulatory Affairs (GRA) Process Excellence function, responsible for driving data governance, reporting, and analytics for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …manage day-to-day operations of MCT technology/digital projects as business function lead , in collaboration with Digital Strategy & Innovation, to align on goals ... and external customers and contributing to training and knowledge sharing activities- Lead the standardization and improvement of MCT operations ; responsible for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of External Vendors by engaging with key cross-functional stakeholders (Clinical Operations , Clinical Biomarkers, QCP, etc.) for establishing data collection, data ... management activities by managing Program / Therapeutic level external data collection process , study requirements as well as the overall process .Accountable for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …creation to end use, working with subject matter experts in various business functions, operations , and IT teams. Create and maintain process maps, data objects ... Data Governance Sr. Specialist as part of the Technical Operations team based in Raritan, NJ. Role Overview We...of the Global Manufacturing & Supply (GMS) data governance process , from material creation to consumption across Warehouse, Materials… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …you ready to experiment with us? The Position The Business Knowledge Management Lead will be responsible for the development of a robust knowledge management system ... for sustained organizational benefit. Relationship Reports to Business Excellence Lead . Collaborates with cross-functional teams, including marketing, analytics, and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ready to experiment with us? The Position The Diagnostics and Precision Health Lead will be responsible for developing and implementing a diagnostics and precision ... to finding patients. Relationships Reports to Integrated TA Strategy Lead . Collaborates closely with cross-functional teams, including therapy area marketing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the people who need them most. The Position As the Manager, Content Operations , you will support Novo Nordisk's strong commitment to its Omni-channel Customers ... them with optimal solution options. Through this role, the Manager will lead definition of business requirements and technical implementation plans in collaboration… more
- Tris Pharma (Monmouth Junction, NJ)
- …Test Results for Pharmaceutical ProductionStrong working knowledge of pharmaceutical investigation process and ability to conduct, lead and/or draft effective ... Jersey, Tris has an immediate opening for a Manager, Quality Management Systems (QMS). Summary:The Manager, Quality Management Systems (QMS) supports, oversees… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Quality Control, Information Technology, Maintenance, Manufacturing personnel, Technical Operations personnel, Human Resources, Site Leadership Team members, and ... decisions. Independently resolves problems through the use of quality systems . Develop improvement ideas and independently implement associated solutions. Support… more
