- Legend Biotech USA, Inc. (Raritan, NJ)
- …quality systems processes.Key Responsibilities Provide oversight to the CAPA program for the CAR-T manufacturing site.Oversee metrics, trending, and reporting of ... departments to resolve issues.Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.Require minimal direction to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and ... of IT security strategy and serving as a security advisor to ensure IT systems are implemented and maintained to the highest security standards. Individuals in this… more
- Eisai, Inc (Nutley, NJ)
- …and CDISC standards. The role will require excellent technical skills in SAS systems and application development and experience. The Associate Director must be a ... highly specialized individual contributor or functional manager with advanced knowledge and expertise to analyze assess and initiate complete programming solution in… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …protocols, reports).Review and approve periodic review documentation for qualified equipment/ systems (audit trails, user groups, system administration)Provide ... of related actions.Perform tasks in a manner consistent with the safety policies, quality systems , and cGMP requirements.Drive continuous improvementOther… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Product Safety Management to upgrade and improve the functioning of various safety systems Develop and manage project plan and timeline; ensure full ... Oversight, maintenance, and ongoing enhancements related to the Patient Support Programs data sources and associated databases. Supporting initial and ongoing… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including ... OverviewThis position will be responsible for maintenance support and mechanical system operations for cGMP Clinical and Commercial Cell Therapy Manufacturing on… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including ... and replenishment. This individual will also work with inventory management systems and execute cycle count and reconciliation activities to ensure inventory… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …plansParticipates in the development, implementation and sustainment of emergency response programs and other safety programsAssists in the creation, tracking ... life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including… more
- Formation Bio (New York, NY)
- …in-licenses drugs from pharma companies, research organizations, and biotechs to develop programs past clinical proof of concept and beyond, ultimately helping to ... of sophisticated models to predict clinical outcomes-determining drug efficacy, safety profiles, and optimal indications-to create a data-driven portfolio that… more
- Merck & Co. (Rahway, NJ)
- …products, with a focus on autoinjectors, prefilled syringes, and other drug delivery systems . The director will lead a team of engineers and technical staff to ... products.Build and enhance device or combination product technology transfer programs in both development and lifecycle management, ensuring compliance with… more
- Eisai, Inc (Nutley, NJ)
- …literature for potential adverse event reports, report findings to Product Safety within established timeframes. Qualifications: Advanced healthcare degree or ... and/or medical/scientific materials. May partner with Sales Training to update training programs , and utilize clinical expertise to present product and disease state… more
- Cerex Advanced Fabrics (Pensacola, FL)
- Cerex Advanced Fabrics, Inc. Electrical & Instrumentation (E&I) Journeyman Level Technician Location: Pensacola, FL area CEREX Advanced Fabrics, Inc. , the ... for the installation, maintenance, troubleshooting, and repair of electrical and instrumentation systems to ensure safe and efficient plant operations . What We… more
- Merck & Co. (Rahway, NJ)
- …cell culture process development for biologics.Experience with high throughput microbioreactor systems , and advanced in situ analytics for process monitoring ... this individual will support late stage and commercial large molecule biologics program activities. The individual will be responsible for leading a team to… more
- Merck & Co. (Rahway, NJ)
- …the mission and vision of the Global Regulatory Affairs and Clinical Safety (GRACS) function of Our Company's Research Laboratories (Research & Development) ... strategy with US FDA and global health authorities to advocate advanced regulatory strategies for novel medicines.Contributing to the continuous improvement of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …a clear, concise format.Perform tasks on time in a manner consistent with safety policies, quality systems , and cGMP requirements.Build strong partnerships with ... life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and ... directly to the Vice President of Enterprise Data & Advanced Analytics (ED&AA) and serves as a key member...improving the performance and efficiency of AI/GenAI models and systems Proficiency in MLOps and machine learning frameworks, including… more
- Tribalco (Boise, ID)
- …around the world. Our Rescue Services Division provides global casualty evacuation systems , safety services, advanced training, and specialized equipment ... and responsibilities include but are not limited to: Conduct safety program reviews, risk assessments, safety...risks. Lead global continuous improvement initiatives to improve global safety programs . Build safety capabilities… more
- Genmab (NJ)
- …as compound and/or indication lead for both early and late-stage programs , and/or as trial responsible statistician with responsibilities as described below. ... CDT including design of trials, analyses and analyses requiring advanced statistical methodologies/techniquesRepresent the CDT/the company at regulatory meetings,… more
- Eisai, Inc (Nutley, NJ)
- …operations staff while strategically planning and managing multiple clinical development programs across different phases.The VP of Global Clinical Operations is ... and CROs on timeliness, completeness, and quality metrics.Manage the Safety Alert Reporting Departments, ensuring high-quality and timely global distribution… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …as needed to help the team, in a manner consistent with safety policies, quality systems , and cGMP requirements.Support manufacturing investigations, ... life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including… more
