- Merck & Co. (Rahway, NJ)
- …and relevant systems (LIMS, MES, SAP). - Experience in data governance, data stewardship, and data quality management in regulated environments. - ... dCMC Regulatory A uthoring L eadership , t he Senior Specialist, Regulatory Authoring Data Analyst, will...Management & Communication : The analyst will organize and lead information gathering sessions with the internal CMC community,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJob Description The Senior Scientist, Device Design Control Lead , is a crucial member of our team, responsible for spearheading design control ... oversee device design control activities to ensure the delivery of high- quality products and efficient manufacturing processes. The role requires extensive… more
- Merck & Co. (Durham, NC)
- …technology transfers as needed.Assist in monitoring process performance and participate in data -driven improvement initiatives under the direction of senior team ... (LMS&T) is seeking a highly motivated individual for the role of Sr . Specialist, Engineering.- This role will provide end-to-end support of manufacturing science… more
- Eisai, Inc (Nutley, NJ)
- …and drive execution as a part of that plan.Champion CQA's mission of ' Quality as enabler of business'; lead global initiatives for continuous improvement.Trend ... capacity, preferred.Significant experience working in multifunctional environments and influencing senior stakeholders using data .Strong performance in earlier… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Job Summary: The Sr . Director, Clinical Safety MD, will lead the development and ... Responsibilities:Depending on the status of development of the compound, lead and medical-scientifically direct a team of physicians and scientists… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. SummaryThe Senior Director of Clinical Operations will manage clinical operations staff to ... and efficient execution of operational aspects of clinical study planning, implementation, data delivery and reporting. Will represent DSPD Clinical Operations in a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …programs. This role involves deputizing for the Sr . Director, representing the Quality organization at senior levels. The Director plays a pivotal role in ... of excellence and compliance and working toward building a quality mindset with Medical Affairs.Support the Sr ....managed activities with the goal of achieving the highest data quality standards, full adherence to patient's… more
- Repligen (Clifton Park, NY)
- OverviewThe Sr . Facilities and Engineering Specialist is responsible for leading and executing complex maintenance, engineering, and facilities operations to ensure ... role manages preventive maintenance programs, equipment optimization, vendor coordination, and quality support, while serving as a technical subject matter expert… more
- Merck & Co. (Rahway, NJ)
- …collaboration with Data Management/Programming.Collaborating cross-functionally to monitor clinical data to ensure quality , completeness, and integrity of ... clinical/scientific execution of clinical protocol(s). This may include:Serving as the lead clinical scientist on the clinical trial team.Leading medical monitoring… more
- Tris Pharma (Monmouth Junction, NJ)
- …New Jersey, Tris has an immediate opening for a Method Validation R&D Senior Scientist ISummary:The Method Validation (MV) Research and Development (R&D) Senior ... and advances required documentations, in liaison with Product Development (PD)/ Quality Assurance (QA)/ Quality Control (QC)/Regulatory Affairs, including… more
- Novo Nordisk Inc. (WA)
- …optimal health outcomes. Are you ready to realize your potential? The Position The Senior Director works on complex issues that require an in-depth knowledge of the ... enables broader PA Team and NNI business to leverage these positions. They lead and manage individual contributors in the Policy team, actively participate with the… more
- Merck & Co. (Rahway, NJ)
- …ability to write SOPs and technical documents and present to peers and senior management.Analytical skills: Ability to analyze complex data and make ... Job DescriptionApplications are sought for a Process Engineering Lead position in o ur Reseach & Development Division Biologics Process Research & Development… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …potential suppliers, manage RFI/RFP and term sheet development, and negotiate contracts. Lead cross-functional teams and collaborate with Quality , Legal, CMC, ... immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Category Sourcing Lead as part of the Global Operations team based in Raritan, NJ. Role… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionIn partnership with the Clinical Quality Operations Lead (CQOL and Head of CQO, the CQOM is accountable for the execution of operational ... quality activities within the assigned therapeutic area.- This includes...addition, the CQOM will work with peers to analyze data across therapy areas in order to identify signals… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …but not limited to Operations, MSAT, Facilities, C&Q, Project Management, and Quality .Work closely with Sr . Manager, Strategic Initiatives to support various ... efficient, and compliant manner.Participate in Risk Assessments, FMEAs, and system/ data process mapping activities.Execute, own, assess and participate in the… more
- Merck & Co. (South San Francisco, CA)
- …realistic, data -driven, and timely decisions.Encourages and maintains the highest quality and rigor of research output and commitment to scientific inquiry, ... plan within CMD, including integration of new technology platforms, human biology, data science, while focusing on uncovering novel biology that delivers high-… more
- Merck & Co. (Rahway, NJ)
- …and interdependencies across DS, DP, Device, Packaging, and Analytical, Regulatory, Quality , and Supply Chain from early development through to commercial ... patients we serve. Problem Solving and Innovative Thinking:-- Gathers and analyzes data and effectively responds to new or complex situations, developing creative… more
- Merck & Co. (Rahway, NJ)
- …Methodologies (separation-based and residuals) and sound scientific understanding of Critical Quality Attributes/QbD/DOE principles as well as data analysis and ... New Jersey research facility. The Principal Scientist is a senior scientific role tasked with working closely with the...the group Director to define group strategy and to lead a team of scientists in solving complex analytical… more
- Merck & Co. (Rahway, NJ)
- …Medical and Scientific Affairs as well as Outcomes Research.Under the guidance of a senior leader, this individual will lead a team of outcomes research ... agencies, and health systems globally. The ability to successfully participate in and lead cross-functional teams is a critical part of this role. The Executive… more
- Formation Bio (New York, NY)
- …obligations to maximize service quality and efficiency. Partner with Legal, Quality Assurance and Data Governance teams to understand and monitor vendor ... ensuring cost-effective and value-driven vendor partnerships. This individual will lead vendor negotiations, implement procurement best practices, and collaborate… more
