- Tris Pharma (Monmouth Junction, NJ)
- Manufacturing Maintenance Mechanic - 1st shift Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned biopharmaceutical company in the US with a focus ... Junction, NJ headquarters has an immediate need for an experienced Facilities Maintenance Mechanic I for 1st shift.The Manufacturing Maintenance Mechanic I… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Supervisor, Maintenance (3rd shift) as part of the Technical Operations team based in ... Raritan, NJ. Role OverviewThe CAR-T Supervisor, Maintenance is an exempt level position working within Technical Operations team. This individual will be responsible… more
- Merck & Co. (Rahway, NJ)
- …(Piping and Instrumentation Diagrams), electrical drawings, and troubleshooting & maintenance techniques. In addition to technical expertise, this individual will ... computer skills including MS office, User Specifications for equipment. General maintenance of processing equipment.Oversee routine and preventive maintenance on… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking an Maintenance Specialist I (2nd and 3rd shift) as part of the Facilities & ... based in Raritan, NJ. Role OverviewThis position will be responsible for maintenance support and mechanical system operations for cGMP Clinical and Commercial Cell… more
- Tris Pharma (Monmouth Junction, NJ)
- …has an immediate opening for a Porter to perform general housekeeping and maintenance of our labs, manufacturing and office areas.This position is a temporary to ... and understand documents and then apply safety rules, operating and maintenance instructions, and procedure manualsWork effectively with others to accomplish the… more
- Genmab (Plainsboro, NJ)
- …person for assigned project(s) and be responsible for the implementation and maintenance of the US regulatory submission strategy For approved products, ensure that ... of the Company Core Data Sheep and US Prescribing Information. Responsible for maintenance of the IND. Monitor and assess global and US regulatory guidelines and… more
- Genmab (Plainsboro, NJ)
- …Sr Manager/Associate Director will be responsible for leading the development and maintenance of global labeling documents (eg, Core Data Sheet, USPI, EU SmPC ... labeling precedent.Act as Global Labeling Lead, supporting development, approval and maintenance of regional labeling (eg, JPI)Manages new projects and projects of… more
- Genmab (Plainsboro, NJ)
- …planning tasks, activities, and deliverablesGlobal Clinical Drug Supply:Support development and maintenance of SOPs for the Global Clinical Drug Supply Operation ... SME knowledge supportCoach and mentor colleagues during onboarding and maintenance of trainingResponsible for oversight and resolution of deviations, CAPAs… more
- Merck & Co. (Rahway, NJ)
- …emissions monitoring.Supports capital project development, operational and maintenance planning, design, and commissioning. Establishes operational performance ... with team members and site management of project progress.Routinely works with Maintenance and Utility departments on preventative and corrective maintenance .… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for the technical support of all equipment and process support installations. A solid maintenance plan forms the basis to make the performance and behavior of the ... for the technical support of all equipment and process support installations. A solid maintenance plan forms the basis to make the performance and behavior of the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …at a time, but example areas may include: Metrics and reporting through maintenance of data connections, data warehousing, and reporting within BI Platforms. Data ... analytics, detections, and automation through SIEM/SOAR content development and maintenance These functions require building and maintaining interfaces between… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and onboarding plans. They will also be responsible for the housing and maintenance of foundational materials required for the CMR LT and CMR organization to ... developed & deployed at the CMR functional level, GxP compliant execution, maintenance of technical training across all CMR functions, and compliance across clinical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Regulatory experience required with a concentration in labeling development and maintenance Proficiency with 21 CFR Labeling, Physician Labeling Rule (PLR), Selected ... Requirements of Prescribing Information, FDA Patient Labeling Resources, Medication Guides, Instructions for Use, National Drug Codes, industry-standard labeling trends, DUNS, and FEI Registrations. An experienced professional having a wide range of experience… more
- Genmab (Plainsboro, NJ)
- …assigned project(s) and be responsible for the development, implementation and maintenance of US/global regulatory strategies (in line with Target Product Profile). ... For approved products, ensure that regulatory strategies throughout life-cycle management are in place and implemented including label improvement, health authority meetings, potential ROW submissions, supplemental BLA submissions, tracking of progress of PMRs… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …support. Direct and perform supporting projects and analyses, as required. Ensure maintenance of applicable tools and systems used for data management and analysis. ... Assists in creating, refining and updating quantitative tracking models and systems, along with documented supporting assumptions. Develop communications materials including slides and reports reflecting clear and concise conclusions and recommendations for… more
- Genmab (Plainsboro, NJ)
- …TeamYou will be part of a highly competent team focused on planning and maintenance of supplies for clinical trials, working closely with the Global Clinical Drug ... Supply Operations & System team and our cross-functional stakeholders.Together with Global Clinical Drug Supply Operations & Systems team the three teams make up the Global Clinical Drug Supply department.We have an international and informal working… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …data, blueprints, and reports. Supports tracking and achievement of annual maintenance goals and objectives including metric improvement targets. Support continuous ... improvement activities such as preventive maintenance optimization, risked based asset management programs, and analyze equipment for proper balance of preventive to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and education required with a concentration in labeling development and maintenance Demonstrated ability to work cross-functionally to develop project plans; ... proactively identify risks; develop risk mitigation strategies; communicate project team decisions and project status Demonstrated ability and knowledge to participate in process/system improvements related to labeling and product/establishment registrations… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …portfolio of technologies, including planning, prioritization, support, and maintenance Experience delivering healthcare-based insights and related models, ... particularly applying informatics techniques Demonstrated experience providing direct user support and leading training initiatives Proven ability to easily grasp and master new software and hardware technologies Excellent communications skills (verbal,… more
- Merck & Co. (Rahway, NJ)
- …Core and Local Labeling documents.You will be responsible for the development and maintenance of Core and US Labeling for assigned products, ensuring compliance with ... internal and regulatory standards.You will assist in the development and maintenance of Local Labeling for EU and other regions.You will serve as a subject matter… more