- Merck & Co. (Rahway, NJ)
- Job DescriptionApplications are sought for a Process Engineering Lead position in o ur Reseach & Development Division Biologics Process Research & Development ... project team as a leader at the detail design phase in preparation for operational readiness.- This is an exciting opportunity to enter the team on the ground… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …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 ... innovation, pioneering work and evolving best practices.The Global Sourcing Category Lead is responsible for leading global sourcing activities for direct materials… more
- Merck & Co. (Durham, NC)
- …This will include leading implementation of innovative technical solutions and operational improvements to achieve targets for safety, compliance, supply, and ... cross-site issues, identify trends and participate in proactively implementing risk mitigation actions.Collaborate with functional teams to contribute to strategic… more
- Merck & Co. (Durham, NC)
- …goals.- This will include implementation of innovative technical solutions and operational improvements to achieve targets for safety, compliance, supply, and ... issues, help identify trends, and participate in the implementation of risk mitigation actions.Collaborate with functional teams to contribute to strategic… 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 operational quality management and inspection management activities.The CQOM will oversee… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including those involving co-development (Alliance) partners. The Early Development (ED) Asset Lead will provide operational expertise for early oncology studies ... including FIH trials and will possess the scientific knowledge to enable operational understanding of deliverables. The ED Asset lead will be able to understand… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and manage presentations and communications for key leadership meetings, and lead change initiatives by deploying operational excellence methodologies across ... art presentation skills, power point, Visio, budget, resources, algorithms, projections, risk management and mitigation. Operational Oversight and Reporting:… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …programs.Partner with Medical Affairs to facilitate the implementation of a risk -based quality management process fully embedded through trial design, execution and ... of successful Health Authority inspections and approvals - Proactively partner and lead the strategic collaboration with other GxP Quality representatives, and act… more
- Merck & Co. (North Wales, PA)
- …strategic acumen, and execution, along with leadership skills to lead complex cross functional projects.Essential Duties and Responsibilities:The engineer will ... leverage their scientific, technical, and business expertise to participate or lead in capital equipment projects, developing network equipment & process standards,… more
- Merck & Co. (San Diego, CA)
- Job DescriptionOphthalmology-Study Manager:Job SummaryThis position leads the operational planning and execution of one or more clinical trials or significant ... skills in support of our clinical trials.-Job ResponsibilitiesResponsible for the operational planning, feasibility, and execution of a clinical trial.-This may… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Raritan, NJ. Role OverviewThis position will be responsible for providing project lead support for strategic initiatives and capacity expansion activities at the ... coordination and collaboration across relevant cross functional groups.Key Responsibilities Lead projects for the implementation of site strategic initiatives and… more
- Insmed Incorporated (San Diego, CA)
- …regulatory representative on cross functional teamsCommunicating regulatory strategies and risk assessments to cross-functional teams and senior leadership, as ... ensure strategic integration of regulatory considerations into program plansIndependently lead the central messaging, preparation, and submission of high quality,… more
- Merck & Co. (North Wales, PA)
- …CMC development plans.--Under the guidance of the CIPM Staff Manager & Portfolio Lead , the core responsibility of this senior Project Manager (PM) role will be ... timeline, cost, and resources- - Talent Development, Process Improvement, and PM Operational Support (~30%)- Fosters a culture that aligns with the organizational… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Risk Management: Ability to identify, assess, and mitigate operational and compliance risks.Technology & Automation: Familiarity with modern manufacturing ... and ensure safe and compliant manufacturing operations according to cGMP requirements. Lead a ~250+ organization responsible for either the non-sterile or sterile… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … operational excellence in a highly regulated environment.Key Responsibilities Lead manufacturing and cross functional investigations from end to end.Ensure ... CAR-T process technologies with a strong focus on compliance auditing, risk assessment, and continuous improvement.The Compliance Auditor will conduct internal… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in Raritan, NJ. Role OverviewThis position will be responsible for providing operational excellence project management support to the cGMP Clinical and Commercial ... plans across functional teamsDefines the interdependent deliverables and ensures that quality, risk , cost, time are managed within the overall approved plan to drive… more
- Aequor (Framingham, MA)
- This project encompasses temporary, support to be the lead point of contact for the shipping validation program during a leave period for the primary program owner. ... shipping validation. Familiar life cycle documentation IQ/OQ/PQ installation qualification, operational and performance qualification Demonstrated expertise in shipping/transport validation… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …solutions to optimize the manufacturing process.Own/support development of site operational models to better understand and assess resource utilization, equipment ... are executed in an effective, efficient, and compliant manner.Participate in Risk Assessments, FMEAs, and system/data process mapping activities.Execute, own, assess… more
- Formation Bio (New York, NY)
- …and implement a company-wide procurement strategy to optimize vendor spend, enhance operational efficiency, and mitigate risks. Lead high-value negotiations with ... ensuring cost-effective and value-driven vendor partnerships. This individual will lead vendor negotiations, implement procurement best practices, and collaborate… more
- Merck & Co. (Rahway, NJ)
- …and mitigates risks across all factors that may impact technical, operational & regulatory success or timelines. -Analyzes and develops innovative solutions ... prioritizing, interrogating and mitigating risks across technical, regulatory and operational factors.- Conducts options analysis and provides recommendation to… more
