- BioAgilytix (Durham, NC)
- … technical concepts clearly and work cross-functionally to align data management goals with BioAgilytix's operational and regulatory requirementsDemonstrated ... of data integrity and compliance.Develop a roadmap for building a high-performing data management team, identifying roles in data engineering, quality,… more
- Merck & Co. (Rahway, NJ)
- …all levels, ensuring their commitment to the technical transfer vision.Risk Management , Compliance Oversight & Decision Making: Lead the establishment of a ... supply.-The role is accountable for ensuring each inline team has robust lifecycle- management plans, appropriate and rigorous technical support processes to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. Summary: The Associate Director, Laboratory Data Management is accountable for the end-to-end delivery of laboratory ... processes and global submissions. This position provides leadership within Data Management by partnering with internal and... data concepts, strong working knowledge of laboratory data processes and industry standards, and technical … more
- Formation Bio (NC)
- …CI/CD pipelines. Establish standards for data governance, observability, and metadata management . Ingestion & Data Modeling Lead development of ingestion ... technical leader to shape the future of our Data Platform. This role is ideal for someone passionate...passionate about building scalable infrastructure at the intersection of data engineering and applied AI. You'll lead … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in regulated clinical trial and / or technical QA activities (ie, eClincial, Data management ).Must have at least 7 or more years of professional experience ... to foster a culture of compliance and accountability in data management practices. The position also involves... technical oversight of QA across GxP (GCP/GVL/GCLP/GLP) systems. Lead the development of the global Data … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for GDX global and regional projects requiring Validation services and Technical Lead assignments.ResponsibilitiesOversee and manage a team of Validation ... rare diseases and immune disorders. SummaryThe Regulated Implementation Services Lead plays a key role in overseeing the development,...Leads and Technical Leads to ensure validation and technical … more
- Genmab (NJ)
- …Data Quality Management , is a strategic leadership role within Clinical Data Management . This individual is accountable for driving the strategy, quality, ... through proactive data quality reviews and analytics.Collaborate with clinical and data management teams to interpret discrepancies and resolve data … more
- Merck & Co. (Rahway, NJ)
- …building end-to-end digital solutions within PSCS, and supporting change management . Systems for manufacturing execution, laboratory data , workflow ... Job DescriptionAn opportunity has arisen for a Sr. Data Scientist in the Pharmaceutical Sciences and Clinical...of scientists, engineers, and IT to broadly shape and lead our identification and internalization of tools to create,… more
- Genmab (NJ)
- …Then we would love to have you join us!The Role & DepartmentThe Feasibility Lead supports the vision and strategy set forth by the Head of Strategic Feasibility. ... Advances this effort through the coordination and development of data -driven early indication and program assessments, study-level feasibility assessments, robust… more
- Aequor (Swiftwater, MN)
- … and timely resolution of technical - Responsible for the master data management process including the updating of specifications and supporting the approval ... through support of master data configuration and data migration and SOP revisions. - Provide technical...environment - Experience in system testing, validation, and master data management - Familiar with 21CFR part… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …while subscribing to the enterprise IT strategy.ResponsibilitiesStrategic Leadership, Platform management and Governance:Implement and lead the global strategy ... solutions within a controlled governance modelIntelligent Process Automation & RPA Implementation: Lead the deployment and optimization of RPA solutions using UI Path… more
- Twist BioScience (South San Francisco, CA)
- …strategy, GxP regulations, industry best practices, and technological advancements in biotechnology . Technical Team Management : Lead , mentor, and develop a ... and documentation, specifically tailored for custom software.Electronic Batch Record (EBR) Management : Lead the design, development, and continuous improvement… more
- Aequor (Seattle, WA)
- …in support of batch history sections for regulatory submissions.Proficiency in data management /statistical analysis software, including Excel, JMP, and Spotfire ... in support of batch history sections for regulatory submissions. Proficiency in data management /statistical analysis software, including Excel, JMP, and Spotfire… more
- Tris Pharma (Monmouth Junction, NJ)
- …an immediate opening for a SR. Manager or Manager, Quality Management Systems (QMS). Title commensurate with experience.Summary:This position supports, oversees and ... company (ie, QA Operations, Quality Control (QC), Manufacturing, Operations, Technical Services, Senior Leadership, etc.) on deviations and PQC investigations… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in improved commercial manufacturing processes and outcomes.The Director will build and lead a high-performing small team of technical experts, fostering a ... Biotech is seeking a Global Director of Platform Innovation as part of the Technical Operations team based in Raritan, NJ. Role OverviewLegend Biotech is seeking a… more
- Merck & Co. (Rahway, NJ)
- …project planning, resourcing, progress reporting, troubleshooting and people management .Provide technical oversight of process development, process ... fourteen (14) years of combination of experience including team management , technical expertise in cell culture, and...and talent management activitiesProven leadership and project management skills to lead cross functional teams,… more
- Merck & Co. (Durham, NC)
- …performance and results of a E2E drug substance/product department and provide technical guidance. Off-shift and weekend coverage will be required based on business ... finances, labor, employee, environment and safetyTactical and strategic Shift(s) management , including collaboration with indirect staff;Promote the behaviors and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …factors with and for other technical departments (eg, Clinical, Medical, Safety, Data Management , Statistics). This position requires skills in working in a ... clinical trial monitoring and execution through RBQM activities. Accountable for the management , performance, and development, both technical and career, of… more
- Merck & Co. (Boston, MA)
- …Quantitative systems pharmacology, Model-Based Drug Development-, or scientific data management .Experience leading cross-functional teams, launching, and ... (RaDS) value team in R&D IT brings together product management , engineering, and data science expertise. We...squads and maintaining product lifecycle Manage scientific applications and lead squads to build user-friendly scientific data … more
- Merck & Co. (Rahway, NJ)
- …toCoordinate project planning, resourcing, progress reporting, troubleshooting and people management .Serve as the scientific/ technical mentor for junior staff.- ... Manufacturing Process Validation, Manufacturing Quality Control, Manufacturing Scale-Up, People Management , Process Improvements, Protein Purifications, Science, Technical … more
