- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Quality Systems Lead as part of the Quality team based in Raritan, NJ. Role ... OverviewThe Quality Systems Lead role is an exempt level position with...assurance, manufacturing compliance, clinical quality, or cell therapy.GxP Quality System knowledge, including relevant regulations and guidances (eg 21… more
- Merck & Co. (Rahway, NJ)
- …review with clinical partners and senior leaders.- - Works directly in the SAP system to establish a consolidated , visible forecast for all study product needs ... in critical non-pipeline activities. - Participate in Interactive Voice Response (IVR) System d evelopment and User Acceptance Testing (UAT) for assigned studies .… more
- Merck & Co. (Rahway, NJ)
- …in both GMP and non-GMP environment Participate in laboratory computer system validation activities associated with new or upgraded instrumentation or software ... to ensure 21 CFR part 11 ComplianceSupport standardization activities for System Development Life CyclePrepare, review, and approve documentation such as master… more
- Merck & Co. (Rahway, NJ)
- …release of drug product across assigned program(s) . - Works directly in the SAP system to establish a consolidated , visible forecast for all product s used within ... the efficiency, accuracy, and effectiveness of clinical supply planning processes and systems . - Stay updated on industry trends, regulations, and best practices… more
- Merck & Co. (Rahway, NJ)
- …assigned studies such as IRT & Microsoft PowerApps. -Works directly in the SAP system to ensure a robust and consolidated forecast for CFGs is maintained. --Report ... and clinical customer relationship management.-Technical Proficiency: familiarity with supply chain systems and software (eg SAP or Oracle) and demand planning… more
- Merck & Co. (Durham, NC)
- …of the Site Automation team responsible for the assigned process control systems in support of manufacturing operations located in Durham, NC.This Individual will ... and engineering groups.- Supports a spectrum of sophisticated automated systems within Manufacturing Operations; providing multiple opportunities to learn new… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …OverviewThis position will be responsible for maintenance support and mechanical system operations for cGMP Clinical and Commercial Cell Therapy Manufacturing on ... pipefitting, and millwright activities associated with the related mechanical systems , utilities, and process equipmentPerform minor upgrades and installations of… more
- Eisai, Inc (Nutley, NJ)
- …to expand, we are seeking highly-motivated individuals who want to work in a fast -paced environment and make a difference. If this is your profile, we want to ... and influence key customers (including local and regional hospital systems ) to sustain a strong organizational presence in the...Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in… more
- Eisai, Inc (Indianapolis, IN)
- …to expand, we are seeking highly-motivated individuals who want to work in a fast -paced environment and make a difference. If this is your profile, we want to ... hear from you. The Area Business Leader (ABL) will engage with assigned health systems for Eisai's oncology portfolio and manage a team of sales professionals. The… more
- Merck & Co. (Upper Gwynedd, PA)
- …Software Development, Software Development Life Cycle (SDLC), Strategic Initiative, System Designs, Systems Integration, Tensorflow, Testing, Version Control, ... (eg, MLFlow, Docker, SageMaker or other cloud-based solutions).Familiarity with version control systems (eg, Git), GitHub actions and CI/CD processes to manage model… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …will be part of Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead and will be responsible for EBR development and administration at ... This individual will support electronic batch record (EBR) updates and system improvements, support applicable process and facility updates, and support… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for the administration and operational support of Daiichi Sankyo's Veeva CRM system within IT. They'll collaborate with various sales and marketing customers to ... API requirements (no development experience required) in and out of Veeva CRM system .- Documentation: Document various system related documentations such as … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in overseeing the development, validation, implementation, and integration of GxP-regulated systems across the organization. This position ensures that all global ... systems , electronic records, validation processes, and regulated applications meet...11, Annex 11); possess a strong understanding of IT system architecture and cloud-based environments.Manage third-party vendors, system… more
- Eisai, Inc (Raleigh, NC)
- …to expand, we are seeking highly-motivated individuals who want to work in a fast -paced environment and make a difference. If this is your profile, we want to ... with entering events, change controls, and complaints into quality management system .Conduct ongoing tracking, documentation, and reporting of quality goals and… more
- Merck & Co. (Durham, NC)
- …in enhancing asset reliability and driving manufacturing excellence in a fast -paced environment. Utilize your engineering expertise and leadership skills to empower ... Site Business Partners.Initiate, Review or Approve changes in the Calibration system (ProCal).Manage approved vendors for calibrations not performed by site… more
- Merck & Co. (Rahway, NJ)
- …teams to integrate security controls seamlessly into existing and new systems .Conducting Security Assessments: Perform security assessments and threat modeling to ... authentication, authorization, role-based access control (RBAC), and federated identity systems (eg, SAML, OAuth, OIDC)On top of that, we...that, we also expect you to match following boxes: Fast learner with the ability to grasp new security… more
- Eisai, Inc (Nutley, NJ)
- …to expand, we are seeking highly-motivated individuals who want to work in a fast -paced environment and make a difference. If this is your profile, we want to ... the Patient JourneyEngage with KOLs affiliated with key regional health systems to understand best practices for establishing diagnostic and treatment algorithmsHelp… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to identify root cause and appropriate corrective actions for equipment system problemsHelps support the optimization of calibration frequencies through a ... provide start-up, commissioning, and qualification/validation support of instrumentation and systems including on-the-floor troubleshooting of equipmentPromotes a collaborative work… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …have experience working within an aseptic manufacturing facility, preferably in training/ system applications, quality systems , or learning management systems ... curriculum in areas of general use, foundational and core skills, systems , unit operations and aseptic processingPrepares and maintains training lab, materials… more
- Eisai, Inc (Nutley, NJ)
- …to expand, we are seeking highly-motivated individuals who want to work in a fast -paced environment and make a difference. If this is your profile, we want to ... and CDISC standards. The role will require excellent technical skills in SAS systems and application development and experience. The Associate Director must be a… more
