- Legend Biotech USA, Inc. (Raritan, NJ)
- …and oversee all engineering management including asset/reliability, data systems/automation and Commissioning/Qualification.Support the development and ... environment.Strong knowledge of building systems (HVAC, electrical, plumbing), construction project management, and sustainability practices.Proven experience managing large capital… more
- Terumo Medical Corporation (Somerset, NJ)
- …knowledge of SAP security concepts, including authorizations, roles, and data access control . + Ability to lead critical issues involving SAP on GCP, Fiori ... security policies, procedures, and configurations to protect sensitive access, data and comply with various regulatory requirements (eg GxP,...the SAP S/4HANA. + Design and implement GRC Access Control . + Assist project manager in security… more
- iconectiv (Bridgewater, NJ)
- …to prioritize and refine user stories, ensuring clarity and alignment with project goals. + **Backlog Refinement:** 1. Lead backlog refinement sessions ... In fact, more than 5K customers rely on our data exchange platforms each day to keep their networks,...fast-paced, iterative environment. + **Sprint Planning:** + Organize and lead two-week sprint planning sessions. + Define sprint goals,… more
- Bayer (Whippany, NJ)
- …necessary; The ability to identify and prioritize the risks of the organization and lead project teams to success; High ethical standards in decision making and ... difference, there’s only one choice. Senior Director, Digital Governance & LMR Lead The Senior Director, Digital Governance & Legal Medical Review (LMR) supports… more
- ValSource, Inc. (Rahway, NJ)
- …ValSource is currently looking to identify experienced and technically skilled leaders with Project Lead and Project Management experience to support a ... ensuring compliance with FDA, GMP, and other regulatory requirements. ResponsibilitiesOn-Site Project Management: Interface with clients, lead teams of… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Scientist, Device Risk Management Lead , is a crucial member of our team, responsible for spearheading risk management efforts in ... will be responsible for device risk management activities in the following aspects: Lead and contribute to thorough risk assessments for both inline and new… more
- Merck & Co. (Rahway, NJ)
- …with regulatory, company, and customer requirements. - Principal Responsibilities Lead /Support continuous improvement initiatives for design control and ... Develop actionable remediation plans and drive their execution through to closure. Lead /contribute to device development, design controls for the assigned… more
- Merck & Co. (Rahway, NJ)
- …operations, and qualification needs.Execute and develop appropriate system validation, change control , and testing documentation in partnership with project CQV ... is a key part of our Chemistry, Manufacturing, and Controls (CMC) hub at our site headquarters in Rahway,...Calibration procedures, Training, and SOPs for all GxP automation systems. Lead integration of control systems with MES,… more
- Merck & Co. (Rahway, NJ)
- …teams, from Research & Manufacturing, in a fast-paced, multidisciplinary environment Lead development of robust and scalable technologies for downstream processes ... Contribute to strategic initiatives; partner with senior leaders to set overall project strategy, and guide teams towards its execution Conceptualize, plan, and… more
- Merck & Co. (Rahway, NJ)
- …are seeking a motivated and experienced Translational PET Imaging Scientist to lead the transition of novel PET radiotracers from late preclinical development into ... submissions, and act as the PET imaging expert within multidisciplinary project teams to ensure efficient clinical translation.Key Responsibilities: Strategy &… more
- Merck & Co. (Rahway, NJ)
- …challenges across projects and functional teams, in a fast-paced, multidisciplinary environment. Lead the development of robust and scalable upstream processes for ... to strategic initiatives; work with senior leaders to establish overall project strategy and guide teams in its execution.Conceptualize, plan, and execute… more
- Merck & Co. (Rahway, NJ)
- …years) in pharmaceutical, biotechnology, or medical devices with proven success in Project management and team leadershipDemonstrated ability to lead and develop ... US and Switzerland, implementing a new operating model and ways of working. Lead a team of technical experts responsible for:Managing systems, equipment and processes… more
- Merck & Co. (Rahway, NJ)
- …People Management, Process Analytical Technology (PAT), Professional Networking, Project Management, Quality Control Management, Regulatory Compliance, ... and microbiological release of pipeline products. The director will provide guidance, lead activities, and strengthen a team of microbiologists whose roles include… 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 ... addition, the CQOM will work with peers to analyze data across therapy areas in order to identify signals...levels of knowledge and skill in order to effectively lead and support GCP inspections, worldwide.- Under the guidance… more
- Merck & Co. (Rahway, NJ)
- …execution of automation-related aspects of our projects.- This role will also lead the execution of projects within Technical Operations and upskill personnel on ... the basics of automation.Specifically, this role will: Lead startup of systems-related aspects of new operational facilities and equipmentLead system-related aspects… more
- Merck & Co. (Rahway, NJ)
- …years) in pharmaceutical, biotechnology, or medical devices with proven success in Project management and team leadershipDemonstrated ability to lead and develop ... US and Switzerland, implementing a new operating model and ways of working. Lead a team of technical experts responsible for:CSO Compliance OperationsCSO Integration… more
- Merck & Co. (Rahway, NJ)
- …- In addition, the candidate will be responsible to establish and lead cross-functional teams through the sourcing process and to provide strategy oversight ... with Target; participation in Market Intelligence activities in connection with Target; data gathering and analysis in connection with Target; others that contribute… more
- Merck & Co. (Rahway, NJ)
- …and ensure raw materials are ordered and available for manufacturing activities Lead data management activities related to communication through FLEx Scheduling ... sites) and external (CMOs) transfer of manufacturing processes. Link to project teams/meetings to drive pre-FLEx manufacturing deliverables. Support in preparation… more
- Merck & Co. (Rahway, NJ)
- …can thrive.Responsibilities include but are not limited to:Partner with functional area project teams and subject matter experts to establish and implement the ... documentation of experiments for the adoption and development of innovative technologies. Lead the design and execution of bench scale process development experiments… more
- Merck & Co. (Rahway, NJ)
- …of DCT deliverables including - robust processes & analytics, an integrated control strategy, successful tech transfer packages, filing and approval, and a robust ... patients we serve. Problem Solving and Innovative Thinking:-- Gathers and analyzes data and effectively responds to new or complex situations, developing creative… more
