- Daiichi Sankyo, Inc. (Bernards, NJ)
- …an enterprise cross-functional QA team to deliver state-of-the-art data-driven solutions. Design a fit-for-purpose organization for operational and technical QA ... including data management, statistical programming, digital technologies, and clinical operations. Design and implement a fit-for-purpose organization responsible for operational… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary: The Senior Director, Head of RBQM (Risk Based Quality Monitoring) sets the vision ... in supporting RBQM activities.- Technical: Provides technical guidance in Quality by Design . Lead the team to define Critical to Quality factors, select critical… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Director (Sr. Principal Scientist) has primary responsibility for the planning and directing clinical research activities involving new or ... span all phases of clinical development (pre-clinical to post-licensure). The Senior Director will manage the entire cycle of late-stage clinical development… more
- Merck & Co. (Rahway, NJ)
- …existing and pipeline products to produce safe, effective, innovative medicine.The Senior Principal Scientist/ Senior Director is responsible for protocol ... for all phases of the trial process, including but not limited to the design , oversight and medical monitoring of Phase I to V clinical trials, preparation of… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Summary We are seeking a Cyber Defense Analytics Senior Specialist with specialized expertise in SIEM engineering and detection content ... Arrangements:HybridShift:1st - DayValid Driving License:NoHazardous Material(s):NoRequired Skills:Computer Science, Cybersecurity, Design Applications, Information Security, Management Process, Security Operations, SIEM… more
- Merck & Co. (Rahway, NJ)
- …dive as well as converse at high technical level with architects and senior scientists. Expertise in data engineering, data science, Machine Learning, or statistical ... and engineers. Working knowledge of statistical methods for DOE design , hypothesis testing, regression analysis, classification, and exploratory data analysis… more
- Merck & Co. (Rahway, NJ)
- …and portfolio management, finance, resource planning and IT master data management.The Senior Specialist of Demand and Capacity Management Solution Architect plays a ... Work Arrangements:HybridShift:Valid Driving License:Hazardous Material(s):Required Skills:Data Engineering, Data Visualization, Design Applications, Software Configurations, Software Development, Software Development Life… more
- Merck & Co. (Rahway, NJ)
- …to join Biologics Process Research & Development (BPR&D) as a Senior Principal Scientist.BPR&D within our company's Research Laboratories (is committed to ... and engage with the scientific community to influence the field.As a Senior Principal Scientist, you will drive various strategic initiatives and translate… more
- Merck & Co. (Rahway, NJ)
- …to join Biologics Process Research & Development (BPR&D) as a Senior Principal Scientist.BPR&D within Research Laboratories is committed to rapidly delivering ... and engage with the scientific community to influence the field.As a Senior Principal Scientist, you will drive various strategic initiatives and translate… more
- Merck & Co. (Rahway, NJ)
- …and scaling-up the formulation, device, and manufacturing process. Driving drug product design from the bench top to the Good Manufacturing Practice (GMP) ... to drive results. - Execute formulation and process development activities using Design of Experiments for new chemical entities or life cycle management… more
- Formation Bio (New York, NY)
- …to patients faster and more efficiently.About the PositionWe are seeking a Senior Director, Biologics to lead all Chemistry, Manufacturing, and Controls (CMC) ... documents; comfort engaging with regulatory authorities. Familiarity with Quality by Design (QbD) principles and their application in CMC development. Demonstrated… more
- Formation Bio (New York, NY)
- …to patients faster and more efficiently.About the PositionWe are looking for a Senior Software Engineer, Applied AI to join our dynamic team at Formation Bio. ... revolutionize the drug development process, this role will center on the design , development, and deployment of advanced machine learning models, including those… more
- Merck & Co. (Rahway, NJ)
- …Sterile GMP Clinical Manufacturing facility.Contribute to equipment and facility design , system commissioning/ qualification, regulatory certification, as well as ... other workstreams' critical activities to enable facility startup and operational readiness.Collaborate closely with the formulation scientists, engineers, quality representatives, and other team members to ensure the quality of the clinical supplies, the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to support Business Strategies.Will contribute to cross functional teams who develop, design , and implement the business and brand strategies. To ensure maximum ... and are prepared to deliver the materials.Will be required to partner with Senior Training Leadership in the identification and selection of vendors to support… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: Senior clinical operational leader accountable for operational planning and execution of ... level. Responsible for clinical program planning and execution (from study design , operational planning, start-up, conduct, reporting, and close out) including… more
- Merck & Co. (Rahway, NJ)
- …Congress and is responsible for regional category management, procurement, and program design for the Travel category.- They will also support regional procurement ... well as global procurement, regional/local TMC&F Operations professionals, and the Global Program Design team in a matrix organization.- In addition, the RCM will be… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Function Team Lead development of strategies for the needs assessment, design , planning, delivery, and evaluation of training across the organization. Work ... governance modelLead training related risk analyses and escalate them to senior leadership in GQAResponsible for development, oversight, and maintenance of GQA… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …studies, prototype development, and advocate for scalable, compliant architecture and design .Collaborate with global quality, IT, and business leaders to align ... leadership experience managing technical and validation teams, preferably at Director or Senior Management level - Required 7+ years of strong expertise in GxP… more
- Merck & Co. (Rahway, NJ)
- …to the Region. This includes continual optimization of the organizational - design and resources, ownership and optimization of key processes, talent and succession ... and - expectations. Participate and support the goals and objectives of the GCTO Senior Leadership - Team (SLT) or extended Leadership Team (eLT). Speak with "one… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …typically a single non-pivotal trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates ... between CRO / vendors / AROAdditional non-study related activities: Occasional senior management interactions at FIHC, WDC; Initiates contact w/KOL and prepares… more
