- Daiichi Sankyo, Inc. (Bernards, NJ)
- …immune disorders. SummaryThe Job holder is responsible for the provision of CMC project lead in the ADC/Bio#2. He/she is responsible for developing/proposing ... ADC/Bio#2 and an integral member of the decision making in the Project lead .ResponsibilitiesDevelop/propose (or have subordinates) integrated CMC product level… more
- Merck & Co. (Rahway, NJ)
- … will expand and manage a team that are responsible for design control activities in the following areas: Lead /contribute to device development and design ... Job DescriptionThe Director, Device System - Design Control plays a pivotal role in combination product development (both design and process), commercialization and… more
- Merck & Co. (Durham, NC)
- Job DescriptionLead Technician, Calibration and Maintenance (O4) Lead Maintenance Technician will be a leader with strong interpersonal, communication, and ... in supporting the manufacturing process. Individual will possess the ability to lead a team, train others and contribute to and implement process improvements.The… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of emerging technologies and trends in the areas to provide informatics project management, SDLC Quality Model, subject matter, and computer system validation ... standard methodology. Oversee applications support groups' system validation and change control process. Collaborate with the Services organization to ensure smooth… more
- Merck & Co. (Rahway, NJ)
- …(SMAR&D) group has an exciting opportunity for a Director role as GxP Strategic Lead based in Rahway, NJ. Join us and experience our culture firsthand - one ... while developing and expanding your career.-- As GxP Strategic Lead , you will be part of a team that...parts of the AR&D organization in aspects of quality control and compliance. Your main responsibilities will include: -… more
- Eisai, Inc (Nutley, NJ)
- …hear from you.The Director, Global IT Governance, Risk & Controls Management Lead is responsible for overseeing the entire portfolio of IT Compliance ... risk assessments.Establish IT security risk assessment framework and compliance control framework.Oversee global IT compliance training programs.Support regional IT… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diseases and immune disorders. Summary The Oncology Early Development Center (OEDC) Program Lead , who directly reports to the Head of the OEDC, supports the OEDC ... with an equally robust and agile infrastructure. The Program Lead plays a central role in supporting OEDC to...all other meetings as necessary.Delivers routine, concise updates on project statuses and next steps and supports thorough preparation… more
- Merck & Co. (Rahway, NJ)
- …role, the successful candidate will be responsible to: Coordinate project planning, resourcing, progress reporting, troubleshooting and people management.Serve as ... multifaceted projects as the leader of a cross-functional team.-Ensures project results meet requirements regarding technical quality, reliability, schedule, and… more
- Aequor (Devers, TX)
- …85000 Position Summary The Sr. Director, Cell Therapy Devens Manufacturing Site IT Lead position plays a critical role in managing all corporate & locally supported ... and will also be part of CTGM IT Leadership Team. DUTIES AND RESPONSIBILITIES: Lead a matrixed organization composed of both site direct reports and groups of… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …This position will interface with Operations, Regulatory, Quality Assurance, Finance, R&D, Project Management and Quality Control departments to complete the ... technology transfer for customers. This position will lead , mentor and grow the Technical Service Department.Job ResponsibilitiesFunction as the customer liaison for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …accountability of team members for deliverables. Additionally, the Risk Assessment lead will communicate across functional and leadership levels to inform all ... the risk, analyze the risk, evaluate the risks and work resources to control the risks based on failure analysis resultsPlan and implement Risk Assessment, support… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …be part of Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead and will be responsible for EBR development and administration at the ... needs to system requirements. Cell/Gene Therapy cGMP manufacturing and project planning experience preferred.Candidates must have hands-on experience with PAS-X… more
- Aequor (Thousand Oaks, CA)
- …Own NC Class II/III records, CAPA, CAPA EV, and more complex change control records. Site performance monitoring: Report contract site performance metrics to site ... lead ; identify improvement opportunities for site performance; daily duties...the contract site as well as internal site team. Project Management and Technology transfers: Follow-up and track activities… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Enhance Demand management process in collaboration with DX Strategy and Project and Portfolio ManagementBRM best practices: Research the latest technology trends ... evaluate the success and impact of technology projects, collaborating with Project and Portfolio Management functionChange management support: Assist in change… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …practices.Develop positive relationships with the QA team, Quality Control , Information Technology, maintenance, Manufacturing personnel, Technical Operations ... Leadership Team members, and peers.Independently makes appropriate and compliant GMP decisions. Lead the establishment and improvement of QA practices to ensure… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …batches by collaborating with all functions (including Quality Assurance, Quality Control , Operations, Vein to Vein, Batch Advocate Team, etc.). Drive discussions ... to ensure necessary hurdles are cleared for batch release and shipment. Lead cross-functional meetings to provide batch release updates, address challenges and… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Health Authority inspections Acquires technical expertise on the function and control of applicable department equipment and techniques related to job function, ... Support, Engineering, EH&S, and OE as directed Serves as project member or project leader on improvement...Knowledge of bioprocessing and GMPs is essential Ability to lead people and projects is required Excellent communication skills… more
- Parsons Corporation (Colorado Springs, CO)
- …what you're looking for. **Job Description:** Parsons is looking for an amazingly talented **Sector Project Control Lead ** to join our team! In this role ... You'll Be Doing:** + Support the HCM Sector Finance Lead , including participating in new business gate reviews, preparing...flow goals. + Recommend and oversee the customization of project control systems to meet specific … more
- UIC Government Services and the Bowhead Family of Companies (King George, VA)
- **Overview** Lead Project Control Specialist (VLIBOPS-2024-21759): Bowhead seeks a Lead Project Control Specialist to join our team in Dahlgren, ... VA. The Lead Project Control Specialists sets up, operates, and monitors, computer systems and devices for acquisition and analysis of data, utilizing… more
- Verista (New Brunswick, NJ)
- …learn from our experiences to enhance our collective expertise Associate Project Engineer Responsibilities: + Manage validation documentation in automated systems, ... including document control and archiving. + Perform quality reviews of IQ/OQ/PQ...CQV and engineering teams to ensure documentation aligns with project milestones. + Assist in audits and inspections by… more
