- Legend Biotech USA, Inc. (Raritan, NJ)
- …OverviewThis position will be responsible for providing Commissioning, Qualification and Validation support to the cGMP Clinical and Commercial Cell Therapy ... product to patients.Key Responsibilities Executes the commissioning, qualification, requalification, validation and any associated maintenance activities within the plantManages… more
- Cipla (Central Islip, NY)
- …related to the manufacturing of tablets and capsules to include delivery, in- process samples in a defined schedule. Review and compile the documents generated ... yield of product with BMR Correctness online. Schedule cleaning validation with request as required for equipment. Work with...and want to ensure that our hiring and interview process meets the needs of all applicants. If you… more
- Merck & Co. (Durham, NC)
- …aptitude, and actively contributes to team performance and process improvements.Key ResponsibilitiesOperational Proficiency:Fully qualified to independently operate ... tasks and transactions independently with minimal assistance.Problem Solving and Process Improvement:Recognizes operational and technical problems, using established procedures… more
- Merck & Co. (Rahway, NJ)
- Job Description Job Description: The Biologics Process Research & Development organization within our Company Research Labs is responsible for developing the drug ... material to supply clinical trials. We are also responsible for commercial process development, and development and implementation of new technologies. We work with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …file library and documentation: manage all files generated during the call-plan process , and ensure files are accurate, reconciled, and distributed to downstream ... and reliable for field users Oversee the field call-plan refinement process : create project timelines, communicate milestones to stakeholders, manage inquiries and… more
- Merck & Co. (North Wales, PA)
- …Primary Activities : Effective analysis and report programming development and validation , utilizing global and therapeutic area (TA) standards and following ... data management concepts Experience in CDISC and ADaM standards Experience ensuring process compliance and deliverable quality Strategic thinking - ability to turn… more
- Merck & Co. (North Wales, PA)
- …automation, and clinical trial operations to guide tool selection and process optimization. Influences Technology and Workflow Decisions Contributes to decisions on ... organizational alignment, and driving implementation through value realization. Defining process and organizational metrics, KRI, KQI, OKRs etc. Demonstrate Agile… more
- Merck & Co. (Rahway, NJ)
- …analytical datasets, tables, figures, and submission deliverables and perform validation activities following departmental SOPs. The senior statistical programmer ... of observational research or statistical terminology and conceptsExperience ensuring process compliance and deliverable qualityStrategic thinking - ability to turn… more
- Merck & Co. (Rahway, NJ)
- …lifecycle. Primary Activities :Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs ... ADaM standardsDemonstrated success in the assurance of deliverable quality and process compliance.Strategic thinking - ability to turn strategy into tactical… more
- Eisai, Inc (Baltimore, MD)
- …support for submission activities while ensuring strategic alignment and process optimization across different regions. It also includes resource planning, ... application of global procedures and standards, and proactively assessing process performance for necessary optimizations. The Associate Director serves as… more
