- Merck & Co. (Rahway, NJ)
- …Develop deep business acumen and expertise in data and data standards across Clinical Development, Medical Affairs, and Regulatory Affairs domains. Apply domain ... knowledge to influence system design, architectural practices, and process improvements on a day-to-day basis. Create target-state business capability maps and value streams aligned with strategic drivers and business objectives. Produce business architectural… more
- Merck & Co. (Rahway, NJ)
- …are as follows:Oversee the outsourcing and coordination of formulation development and clinical manufacturing at Contract Research Organization (CROs)/Contract ... Manufacturing Organizations (CMOs) conducted by project managersProvide manufacturing and compliance expertise to project teams and junior ExDM membersIdentify and sponsor continuous improvement projects for the workflows within the groupBuild networks within… more
- Merck & Co. (Rahway, NJ)
- …extensive experience in design controls, device transfer, control strategies, device risk management, and design verification testing to develop value-added solutions ... for medical devices and combination products.Provide support for the external partner component manufacturing, release and distribution to global manufacturing sites.Identifying issues with minimal signals, problem solving, identification of root cause provide… more
- Merck & Co. (Rahway, NJ)
- …Knowledge of regulations governing pharmacovigilance for veterinary medicinesExperience with PV databasesStrong analytical, communication, and writing ... skillsExperience with biostatistics and epidemiological principlesAnimal Health/Animal Science background is highly preferred REQUIREMENTS: DVM or PhD in a clinically/scientifically relevant fieldCurrent Employees apply HERE Current Contingent Workers apply… more
- Merck & Co. (Rahway, NJ)
- …Skills & Experience RequiredDegree in Business, Agriculture, Animal or Life Sciences, Veterinary Medicine or related field; MBA preferred10+ years of experience in ... key account management or general management roles within Animal Health, AgTech, Medical Devices or related industriesStrong understanding of livestock production processes, genetics and/or medicalizationProven track record of building strategic relationships… more
- Merck & Co. (Rahway, NJ)
- …Position Description The Chemical Engineering Research & Development department (CERD), part of the Process Research and Development organization, is seeking highly ... motivated individuals who are looking for an opportunity to work in a fast-paced job that provides a high degree of technical responsibility.- This position involves hands-on process development/scale-up work performed at scales spanning the range from… more
- Merck & Co. (Rahway, NJ)
- …Leads our Company's Investigator Initiated Studies program in assigned therapeutic areas ensuring scientific rigorProvides subject matter expertise for Product ... Development and Publications teams and facilitates cross-functional communication and collaboration in pursuit of our company's R&D strategyLeads R&D activities and synthesizes competitive intelligence relevant to our company's R&D strategy at key scientific… more
- Merck & Co. (Rahway, NJ)
- …Senior Director (Senior Principal Scientist) has primary responsibility for planning and directing clinical research activities involving new or marketed ... cardiovascular and respiratory medicines. With a focus on late-stage development, the Senior Director will manage the entire cycle of clinical development, including study design, initiation, execution, monitoring, analysis, regulatory reporting, and… more
- Merck & Co. (Rahway, NJ)
- …Strategic Leadership and Project Management: Provide leadership in the development, commercialization, and transfer and sustained launch of medical devices and ... combination products globally.Develop and execute strategic plans for technology transfer, problem-solving, leading working group in late stages of development, and working collaboratively with receiving sites, drug product partners, and Technical Product… more
- Merck & Co. (Rahway, NJ)
- …and ManagementServes as a senior leader in the US Medical Affairs (USMA) organization, sets the strategic direction for the Therapeutic Area (TA) program, and ... oversees the execution of the field medical team of Regional Medical Scientific Directors (RMSDs).Assesses and determines US strategy and tactical plans for TA aligned deliverables that align with V&I Goals and serves as the Lead for the US Medical Affairs… more
- Merck & Co. (Rahway, NJ)
- …of all stakeholders, building an SME network, and facilitating the use of enabling tools or technologies such as SAP. The Process Steward Team members enable the ... Job DescriptionThe Global Clinical Supply (GCS) organization is part of our company's Research Laboratories and is accountable for managing the end-to-end integrated clinical supply chain across our company's portfolio to enable the execution of any clinical… more
- Merck & Co. (Rahway, NJ)
- …The Senior Scientist, Device Design Control Lead, is a crucial member of our team, responsible for spearheading design control efforts in combination product ... development, commercialization, and lifecycle management. This individual will oversee device design control activities to ensure the delivery of high-quality products and efficient manufacturing processes. The role requires extensive collaboration with… more
- Merck & Co. (Rahway, NJ)
- …certifications, experience, skills, geographic location, government requirements, and business or organizational needs.The successful candidate will be eligible for ... annual bonus and long-term incentive, if applicable.We offer a comprehensive package of benefits.- Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid… more
- Merck & Co. (Rahway, NJ)
- …Minimum Educational Requirement and Experience: Bachelor of Science (BS) Degree in relevant engineering or science fields with fifteen (15) years of relevant ... experience, or Master of Science (MS) Degree with twelve (12) years of relevant experience, or PhD with ten (10) years relevant experience Required Experience and Skills :Strong cross divisional networking skills and capabilitiesDemonstrated functional and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Be part of the manufacturing operations team responsible for production of autologous CAR-T products for clinical and commercial operation in a controlled current ... Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Support process operations by performing support specific and real-time floor service tasks (ie, kitting and kit cleaning, inventory management and data entry, sample ... Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Lead the team responsible for QA oversight of final CAR-T product batch record review and release practices.Lead the establishment and improvement of QA practices to ... Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Participate in Vein-to-Vein, S&OP (CRR), Site Supply Chain, and Operations meetings (eg, Production Ramp Up plan) to assess manufacturing constraints and prioritize ... Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Lead global sourcing for assigned direct materials category for a fast-growing commercialized CAR-T product.Develop a long-term category strategy aligned with product ... growth and supplier diversification.Support building a high-performing global sourcing organizationAssess and periodically update risk scores for BOM and other high-risk materials.Co-develop sourcing scoreboards, KPIs, and metrics to enhance visibility across… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Ensure the timely completion of high-quality robust investigations with appropriate root cause(s).Ensure appropriate Corrective and Preventative Actions (CAPA's) are ... developed and implemented.Escalation of events to management that potentially represent significant quality issues or issues resulting in the delay of investigation closure and product release.Support regulatory inspections and audits by ensuring inspection… more
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