- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking a Maintenance Specialist I (3rd shift) as part of the Facilities & Engineering team based in Raritan, NJ. Role OverviewThis position will ... be responsible for maintenance support and mechanical system operations for cGMP Clinical...upgrades and installations of facilities and systemsPerform on-site equipment maintenance and critical utilities maintenance operations, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …vendors and the global CSPV team. This position assists in the monthly maintenance and reconciliation. This position is expected to handle ICSR issues in accordance ... as well as creating/retrieving case file folders. Reconciliation: Performs monthly maintenance and reconciliation of trackers for safety data exchanged with license… 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)
- …of the CDR/AP system(s) including the areas of study setup, creation and maintenance of standard hierarchy structures and user access controls for all clinical ... administration activities within the CDR system may include the creation & maintenance of standardized and custom user roles and data hierarchies, assignment of… more
- Merck & Co. (Rahway, NJ)
- …We're seeking a talented Technician to join our team. Provide mechanical maintenance support to facilities & utilities for Rahway, New Jersey pharmaceutical research ... campus and headquarters for our company.Support day-to-day preventative and corrective maintenance for assigned area(s) and may include technical input to mechanical… more
- Merck & Co. (Rahway, NJ)
- …to help develop and implement a global strategy for registration and/or maintenance of products.- Responsibilities may encompass all aspects of planning and ... other functional areas (eg, clinical research, non-clinical safety assessment). Support maintenance (eg, quality compliance and life cycle management) of oncology… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …CMOs with respect to the facility, equipment lab instruments, engineering, maintenance , computerized systems and validation activities which complies with GMP ... guidelines such as ICH and PIC/s as well as FDA regulation requirements, industry best practices and will withstand regulatory inspections by regulatory authorities and regular audits.Drug Product Management: Supports technically the operational activities… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …impact assessments and implementation of changes as required.Lead development and maintenance of RBQM standards such as guiding principles, risk, quality tolerance ... limit (QTL) libraries, and critical-to-quality factors.Lead RBQM Center of Excellence for central statistical monitoring topics, ensure optimal utilization of the cross functional SMEs to embed RBQM across portfolio of studies and ensure adoption.Engage with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …data quality and security, supported by regular audits, data maintenance and continuous improvement processes.Project Management: Effective management of timelines ... and deliverables, along with experience in Agile and Waterfall methodologies, is essential. Preferred SkillsPractical experience in SuccessFactors as a functional consultant or configurator or SuccessFactors Certification would be highly regarded… 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
- Merck & Co. (Rahway, NJ)
- …is seeking an experienced Trademark Renewal Specialist to provide trademark maintenance and docketing support to the Intellectual Property (IP) organization. Primary ... amended trademark rules and docketing procedure to ensure all maintenance requirements are metAssist in operational excellence initiatives making appropriate… 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
- Merck & Co. (Rahway, NJ)
- …and supporting work processes. - Ability to develop and implement effective maintenance strategies, including preventive and predictive maintenance programs that ... ensure the longevity and safety of facility equipment. - Demonstrated ability leading technical teams.- - Strong analytical skills to identify problems, evaluate potential solutions, and implement effective corrective actions. This includes troubleshooting… more
- Merck & Co. (Rahway, NJ)
- …with GxP, GmP, and other highly complaint system implementation and maintenance best practices.Current Employees apply HERE Current Contingent Workers apply HERE ... US and Puerto Rico Residents Only:Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We… more
- Merck & Co. (Rahway, NJ)
- …Experience with flow cytometers (eg, BD, Cytek) including maintenance , troubleshooting, and performance optimization.Data Analysis Skills:-Proficient in data ... analysis and interpretation, using software tools such as FlowJo, OMIQ, and FCS Express, with the capability to derive actionable insights from complex datasets.Regulatory Knowledge: Understanding of regulatory guidelines (FDA, EMA) pertaining to biomarker… more
- Merck & Co. (Rahway, NJ)
- …Services: IFM, Real Estate, Office Supplies and Furniture, Industrial Gases, Maintenance Repair and Operations (MRO), and Archiving.The selected candidate will play ... a pivotal role in supporting both current and new business transformation projects within the CSS organization. You will bring the necessary discipline, execution, and implementation skills to facilitate numerous initiatives managed by the CSS team, while… more
- Merck & Co. (Rahway, NJ)
- …with IT teams for system configuration, infrastructure, and maintenance .Implement best practices, SOPs, Metrics, and continuous improvement for ... SAP operations.Team ManagementLead a team of -~125 employees, including global tech centers in Prague and Singapore and new tech center in India (2025)Provide leadership and coaching to global teams.Develop a multi-year digital capability roadmap aligned with… more
- Merck & Co. (Rahway, NJ)
- …, including sample preparation and optimization , mass spectrometer operation and maintenance , and data interpretation and analysis.- - Familiarity with Gene d ata ... or other MS software .- - Excellent oral and written communication skills .-- - Proven track record of peer-reviewed publications. - - Preferred Experience and Skills - Experience in organic chemistry. - Experience in LC-MS based assays including peptide… more
- Merck & Co. (Rahway, NJ)
- …including use case identification, discovery all the way to development and maintenance .Knowledge about specialty products, SP and Hub data and experience with ... patient journey and risk stratification is a plusTranslate use cases into implementation roadmaps to deliver high quality data productsEstablish common performance expectations and processes for data product owners, data analysts and scrum masters.Leverage… more
- Merck & Co. (Rahway, NJ)
- …scientific nomenclature to meet the diverse needs of the businessSupporting maintenance and testing for the reference data systems, including SDLCIdentifying ... opportunities to improve efficiency, effectiveness and quality and implement changesBuilding and maintaining excellent relationships with end users/stakeholders, including outreach and engagementIdentifying, evaluating, and/or developing new reference data… more
