- 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking an Maintenance Specialist I (2nd or 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)
- Facilities Maintenance Mechanic - 1st shift Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned biopharmaceutical company in the US with a focus on ... headquarters has an immediate need for an experienced Facilities Maintenance Mechanic I for 1st shift.The Facilities Maintenance... Maintenance Mechanic I for 1st shift.The Facilities Maintenance Mechanic I is responsible for 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
- 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …with Quality Assurance, Manufacturing, Technical Operations, Engineering and Maintenance to support business needs.Perform tasks in a manner ... include quality Assurance, Manufacturing Operations, Technical Operations, Engineering and Maintenance , Supply Chain and Planning.- Job Duties performed routinely… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets (CCDS) for assigned products. This position ... drives/leads the maintenance of global labeling and associated documents (including cartons and external packaging in the US) for assigned Daiichi Sankyo products.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …& Pharmacovigilance (CSPV) for assigned products. This position drives/leads the development and maintenance of the CCDS, US and EU labeling, and manages the review ... partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets (CCDS) for assigned products. This position… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Executes the commissioning, qualification, requalification, validation and any associated maintenance activities within the plantManages multiple and complex CQV ... projects, provides status reports and coordinates with other departments or outside contractors/vendors to complete tasksSupports and/or owns technical and quality investigations, CAPAs and correctionsDevelops and performs any required remediation efforts and… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …relationships with the QA team, Quality Control, Information Technology, maintenance , Manufacturing personnel, Technical Operations personnel, Human Resources, Site ... Leadership Team members, and peers.Independently makes appropriate and compliant GMP decisions.Lead the establishment and improvement of QA practices to ensure accurate documentation of all review and release activities for drug products, including manual 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …relationship with the QA team, Quality Control, Information Technology, Maintenance , Manufacturing personnel, Technical Operations personnel, Human Resources, Site ... Leadership Team members, and peers.Harmonize with Environmental, Health, and Safety personnel, Product Development, and Quality/Manufacturing personnel.Independently makes appropriate and compliant GMP decisions.Independently resolves problems through the use… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …requirements across studies related to a similar compound. Develops and oversees the maintenance of the study specific SAE Flow Plan and collaborates with on behalf ... of CSPV Operations any other study related documentation such as the DMP, SOWs, PVAs, Clinical Study Oversight Plans, day-to-day management of DS Safety Notification Letter (SNL) System and presentations and documents.Electronic Data Capture (EDC)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with the GCL, if applicableDelivers all relevant components needed for maintenance of product licenses (eg, Core Data Sheet generation/revision; clinical ... benefit-risk assessments for license renewals, responses to Health Authority)Participant and voting member in the labeling development process in the Labeling Working Team (LWT), in collaboration with the CDLContributes from a medical strategy standpoint to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …plans, including training and support models, to ensure ongoing system maintenance and performance. Qualifications: Successful candidates will be able to meet ... the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university)- Bachelor's Degree Bachelor's degree in computer science, information systems or related field required Experience… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …organization to ensure smooth transition from system implementation to maintenance . Identify, assess, and mitigate technical, regulatory, and operational risks ... while ensuring these systems are inspection and audit ready. Overall accountability, ensuring higher quality project outcomes with optimal use of resources.- Provide such reports that are required to update both management and the business on the progress and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and ensure accurate and high-quality deliverables. Ensure documentation and consistent maintenance of code, logs and output within a regulated computing ... environment.Create and maintain specifications as per CDISC SDTMIG. Perform SAS programming to provide complex data review listings and reports to support Data Management and clinical teams. Develop, implement and maintain SAS programming standards and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …& Pharmacovigilance (CSPV) for assigned products. This position drives/leads the development and maintenance of the CCDS, US and EU labeling, and manages the review ... of country labeling deviations for assigned Daiichi Sankyo products ensuring compliance with all applicable Health Authority (HA) regulations and guidelines, internal company procedures and company business objectives. This position manages new projects and… more
