- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders.Summary Accountable for support and manage Quality Management System (QMS) in accordance with regulatory requirements and to ... and current regulatory requirements tracking all the complaints, deviations and change control related with the product and creating a trend evaluation scenario… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in a manner that facilitates Health Authority reviews.- Supports company`s GMP Change Management Program. Evaluates CMC changes for portfolio biologics and ... regulatory CMC representative to project teams, and supports change implementation. Coordinates with regional/global RACMC, Quality Assurance, Pharmaceutical … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Validation Plans, Protocols (IQ/OQ/PQ), Test Scripts and Summary Reports.Support the change management process for validated systems where necessary.Maintain ... 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… 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 ... Implementing strategic and tactical plans to drive sustainable improvements.Supports Regulatory Affairs in providing quality content and review of documents… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …functions include: Clinical Operations, Clinical Development, Biostatistics and Data Management , Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical ... of people globally by leveraging our world-class science and technology . With more than 100 years of scientific expertise...Safety and Pharmacovigilance, Regulatory /Risk Management , Quality Assurance, Medical Affairs, Translational… 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 ... will work in areas required for the good day-to-day management of data at Daiichi Sankyo including: the stewardship...functions, domain experts in privacy, security, and compliance and technology and IT owners from the digital transformation unit,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …unmet medical needs of people globally by leveraging our world-class science and technology . With more than 120 years of scientific expertise and a presence in ... the IT functions. This role involves developing the HCP Engagements technology roadmap, leading innovation, communication strategies, identifying and managing KPI's,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …unmet medical needs of people globally by leveraging our world-class science and technology . With more than 120 years of scientific expertise and a presence in ... organizational units or project teams. This position has advanced skills in technology systems, content creation, word processing software and data management … more
- Merck & Co. (Rahway, NJ)
- …drive new ideas, but also have pragmatic approach to development options, technology selection and regulatory postureDemonstrated working knowledge of FDA, ICH, ... formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products… more
- Merck & Co. (Rahway, NJ)
- …drive new ideas, but also have pragmatic approach to development options, technology selection and regulatory postureDemonstrated ability to identify, mitigate ... biopharmaceutics technical & domain expertise, effective communication skills, understanding of regulatory environment, and vision to influence the regulatory … 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 ... decisions including approach for tech development, manufacturing network strategy, and change control strategy/planning as chair of PAC-MT, etc.Manage (or have… more
- Merck & Co. (Rahway, NJ)
- …the activities of lab staff, including scheduling, training, and performance management .Ensure adherence to safety protocols and regulatory requirements within ... GMP product testingExperience in leading and supporting quality investigations and change managementExperience with internal / external audit process and authoring… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …knowledge in maintenance/metrology management , broad understanding of facilities management , cGMP compliance, EHS and regulatory standards (eg EPA, ... lead with influencecGMP manufacturingMaintenance, metrology, and facilities managementComputerized maintenance management systems (CMMS)EHS and regulatory standards (eg… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to manage process platform changes/improvements in a global manufacturing network and change management process.Candidate must have extensive experience in Cell ... and CMOs preferred. Extensive knowledge in process and analytical development, technology transfer, process comparability and qualification, CMC regulatory … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …strong communication skillscGMP manufacturingMaintenance, facilities and utilitiesComputerized maintenance management systems (CMMS)EHS and regulatory standards ... we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to manage process platform changes/improvements in a global manufacturing network and change management process.Candidate must have extensive experience in Cell ... external partners and CMOs preferredExtensive knowledge in process development, technology transfer, process comparability, CMC regulatory guidelines, process… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …change controls and complaintsReview and approve manufacturing proceduresSupport regulatory inspections and audits by ensuring inspection readiness within ... we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …supporting corrections and CAPAs.Lead continuous improvement associated with investigation management .Support regulatory inspections and audits by ensuring ... we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …regulatory submissions, risk assessments, validation impact assessments, global change controls, draft industry guidelines, specification & critical limitsServes ... we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell 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 and ... system/equipment changes from identification through implementation/release, including the associated Change Controls.Develop/own asset lifecycle documentation from URS development to… more
