- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. JOB SUMMARYThe Associate Director, GMP QA Process Excellence is accountable to collect information, ... analyze quality related process, define strategies to lead to the...strategies to lead to the development and implementation of quality improvement initiatives across the organization.This role will focus… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …global markets are also met.Cross-Functional Team Participation: Responsible for working with Quality Leaders in each operating site to influence and affect the ... timely manner activity and a protective solution to avoid any risk to the quality and safety of commercial and investigational drug products supplied through DSI and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …direction to Biostats Data Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population and protocol compliance for ... Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment with Delivery Lead eg review Tables/Listings/Graphs before… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …experience requiredKnowledge of FDA regulations. preferred Competencies: Delivers high quality work, assesses individual and vendor/CRO work with minimal ... supervisionExecutes strategic plans within multiple projects and can prioritize in accordance with strategy.Competent in identifying and understanding issues independently and can contribute to remediation plansCompetent knowledge of pharmacology, clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes Processes and Best Practices: Reinforces labeling best ... practices at cross-functional meetings. Assists in the development of Standard Operating Procedures (SOPs) and process improvements. Follows agreements with external partners.Department Coordination: Builds cross-functional and cross-regional… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of statistical activities; collaborates closely with data manager to ensure high quality data.- Drug Development Strategy: Provides input to multiple aspects of the ... development plan to ensure the study designs at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.- CRO / Vendor Oversight: Review CRO/vendor proposal and budget.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …relevant advancements to optimize system performance and functionality. - Data Quality , Testing and Release ManagementEstablish and enforce robust data governance ... test, audit and validate HR data to maintain high data quality standards.Conduct system audits, optimize performance, and troubleshoot technical issues.Develop… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …smooth transition with other sub projects with respect to supply, product quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior ... CMC Lead regarding the activity status and potential critical issues, or to the governance bodies. Responsibilities - Accountability to lead teams within overall CMC development project(s), to support Sr CMC Lead. In case no Sr CMC Lead is established, take… more
- Merck & Co. (Rahway, NJ)
- …Modeling Team in our Company Manufacturing Division seeks an experienced Associate Principal Scientist who will develop and utilize advanced computational models ... reduced costs, fewer experiments and batches, faster timelines, improved quality and process robustness.-Demonstrate creativity in solving complex, physical/biochemical… more
- Merck & Co. (Rahway, NJ)
- …within TMB is seeking a highly motivated and skilled individual for the Associate Principal Scientist position. This role is vital for the development, validation, ... with CROs, demonstrating skills in clear communication, protocol transfer, quality agreements, secure data transfer, and regulatory compliance.Proficiency in… more
- Merck & Co. (Rahway, NJ)
- …a lead GCS Planning program representative ) such as clinical development, regulatory, quality and other supply chain areas to negotiate timelines ,- strategies and ... software . - Familiarity with Good Manufacturing Practices (GMP) requirements, quality procedures, and Standard Operating Procedure (SOP) execution. - GCSCareer25… more
- Merck & Co. (Rahway, NJ)
- …CSS team with IS&O initiatives and daily operations, adopting high- quality change practices and embodying our Companys Enterprise Leadership Skills.Stakeholder ... trust through effective communication and relationship management.Execution Excellence: Deliver high- quality outputs within deadlines while navigating ambiguity.Business and Technology… more
- Merck & Co. (Rahway, NJ)
- …journey to become the premier "Data First" commercial biopharma organization.In this Associate Director Data Product Management role, you will be part of the ... a plusTranslate use cases into implementation roadmaps to deliver high quality data productsEstablish common performance expectations and processes for data product… more
- Merck & Co. (Rahway, NJ)
- …cross-functional team.-Ensures project results meet requirements regarding technical quality , reliability, schedule, and cost.Monitors performance and recommends ... substance comparability, scale down establishment, computational fluid dynamics (CFD) modeling, Quality by Design (QbD) and Lean Six Sigma principles. Experience… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Director of Scientific Nomenclature and Reference Data is responsible for assigning accurate chemical nomenclature to small molecules ... scientific background, excellent communications skills, and project management skills to derive high- quality reference data to meet the diverse needs of the business… more
- Merck & Co. (Rahway, NJ)
- …and innovative real estate and workplace solutions aligned with corporate strategy.The Associate Director of Real Estate Strategic Planning will play a crucial ... skills and meticulous attention to detail, with a commitment to delivering high- quality work.Leadership experience with a demonstrated ability to mentor and guide… more
- Merck & Co. (Rahway, NJ)
- …contributions and scientific supervision of a biochemical team, the Associate Principal Scientist collaborates with cross-functional teams to deliver manufacturing ... drive efficiency and yield improvements. Additionally, the candidate will utilize Quality Risk Management methodologies and statistical design of experiment tools to… more
- Merck & Co. (Rahway, NJ)
- …for traceability / lineage and make them available for business consumption; Monitor data quality report and work proactively with IT on data issues as part of daily ... reconciliation process; Check the accuracy of the master and operational data which impacts dashboard reporting.Responsible for Data Management, that entails: Maintain Standard pricing across all species at multiple Units of Measure and load all Special… more
- Merck & Co. (Rahway, NJ)
- …with understanding of Design Controls (21 CFR 820.30)Familiarity with the following standards: Quality Management - ISO 13485, Risk Management - ISO 14971, EU MDR, ... ISO 11608 Needle-based injection system for medical use.Familiarity with Design Verification (DV) strategies and mechanical tests with validations, including engineering studies, design verification protocols, stability studies and validation protocols,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking a Warehouse Operations Associate as part of the Warehouse & Logistics team based in Raritan, NJ. Role OverviewThe Warehouse Operations ... Associate will be part of the Technical Operations Supply...warehouse space. Assist in regulatory inspections, perform safety and quality audits, and answer relevant questions about packaging, methods,… more
