- Merck & Co. (Rahway, NJ)
- …Global Process Lead (GPL) is responsible for overseeing and managing Global Regulatory Affairs & Clinical Safety (GRACS) global business processes. This includes ... management and continuous improvement.-Establish and lead assigned domain Global Process Control Boards (GPCBs), accountable for successful design and performance of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Operations Inventory Control Specialist as part of the Technical Operations ... team based in Raritan, New Jersey. Role OverviewThe Operations Inventory Control Specialist will be part of the Raritan CAR-T Operations team responsible… more
- Merck & Co. (Durham, NC)
- …reductions, and standard work at the shop floor level. Collaborates with Operations , Technology and Quality to author regulatory inspection observation responses ... Job DescriptionOur Manufacturing Operations teams are the people that make our...revise Standard Operating Procedures Support of internal and external regulatory inspections, presenting on topics as needed. Day shift… more
- Insmed Incorporated (San Diego, CA)
- …paced, collaborative, and multidisciplinary team. This individual will join the Quality Control leadership team. As the QC Stability and Sample Management Manager, ... be responsible for the daily oversight for the QC stability and sample management operations in support of routine GMP operations at Insmed Gene Therapy. The… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …per DSI Internal control - Support the Head Global QA strategy and operations to develop and plan the Global QA communication strategies and manage the ... Leadership members as well as Head Global Strategy & Operations (RDPVMA QA). This position also performs support tasks...to individuals are current and up to date- Support regulatory inspection related activities as required such as organizing… more
- Merck & Co. (Rahway, NJ)
- …alignment with the company's business goals, and quality and regulatory compliance.-Essential Duties and Responsibilities:Program Leadership and Technical Project ... with receiving sites, drug product partners, and Technical Product Leaders, regulatory and quality.Provide Voice of Manufacturing input to early development teams… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for support and manage Quality Management System (QMS) in accordance with regulatory requirements and to ensure the adherence to the Quality Manual. Responsible ... adherence to the implementation of global and harmonized Quality Standards and regulatory requirements for GMP area. Responsible for the creation and review Quality… more
- Merck & Co. (Rahway, NJ)
- …oral, sterile and combination products. You will also contribute towards regulatory submissions to enable clinical trials. Your main responsibilities will ... guiding product and process development.Defining and implementing end-to-end analytical control strategies for clinical supplies under good manufacturing practices… more
- Merck & Co. (Durham, NC)
- …or InstrumentationPreferred 5 years of plant maintenance and familiarity with regulatory requirements in accordance with GMP manufacturing operations Operation, ... and oralEffective maintenance, troubleshooting, and problem-solving skillsWorking knowledge of regulatory requirements in accordance with GMP manufacturing operations… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …myeloma.Legend Biotech is seeking Investigation Supervisor as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe CAR -T Investigation ... productivity, yield, and cost.Implement process improvements within the change control system.Recognize and act on potential compliance issues and opportunities… more
- Merck & Co. (Durham, NC)
- …HVAC, and/or multi-stage refrigeration systems) Required Experience and Familiarity of regulatory requirements in accordance with GMP manufacturing operations ... Effective maintenance, troubleshooting, and problem-solving skills Working knowledge of regulatory requirements in accordance with GMP manufacturing operations .… more
- Merck & Co. (Durham, NC)
- …member of the Focus Factory Automation team responsible for the assigned process control systems in support of manufacturing operations located in Durham, ... coordination leadership and implementation of troubleshooting activities and change control .Initiate and lead collaboration within the Operations , Quality… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to be qualified/validated based on corporate/site guidelines, procedures, regulatory guidelines, and industry practicesStrongly interface with Operations ... is seeking Validation Technician, Aseptic Process as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe Process Validation Technician will… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …or other supplemental studies to support development of Dx devices under design control process. They will lead identification and selection of Dx assays and ... members of Global Companion Diagnostics, Translational Sciences, Global Clinical Operations , Biostats and Data Management and Clinical Development. Responsibilities… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …is seeking a Master Data Governance Sr. Specialist as part of the Technical Operations team based in Raritan, NJ. Role OverviewWe are actively seeking a proficient ... leader, with strong understanding of Manufacturing & Supply Chain Management operations , who can translate operational and technical data requirements, into… more
- Merck & Co. (Durham, NC)
- …Primary duties of this position will focus on the daily quality control lab operations .- Responsibilities Support routine release testing Complete appropriate ... with our incredibly high standards of quality and meets all regulatory requirements.- Partnering across our internal manufacturing facilities, external contract… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Japan, and other global sites. These business functions include: Clinical Operations , Clinical Development, Biostatistics and Data Management, Regulatory ... Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory /Risk Management, Quality Assurance, Medical Affairs, Translational Research, Research,… more
- Merck & Co. (Rahway, NJ)
- …allow individuals to gain knowledge on products, healthcare systems, payors, and regulatory and reputational risks while working intimately with our global business ... operations .-In addition, individuals will use data analytics to gain...with various datasets to drive real-time risk assessments and control insights utilizing Power BI and other Microsoft applications.Experiment… more
- Merck & Co. (Durham, NC)
- …our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, externalcontract ... order to maintain compliance with legal.regulations, health and safety, and regulatory requirements as written.Works in a team environment to accomplish departmental… more
- Merck & Co. (Rahway, NJ)
- …of connectivity between the functions supporting the pipeline (ie- quality, regulatory , clinical development; chemistry, manufacturing, and control (CMC); supply ... critical thinking. Additional responsibilities include authoring technical reports and regulatory documents, presenting technical data, and project management. You… more
