- Daiichi Sankyo, Inc. (Bernards, NJ)
- …adherence / metrics to proactively address operational risksServe as a regional Process expert regarding maintaining a compliant set of procedural documentsWork ... research areas centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global Regulatory Affairs… more
- Merck & Co. (Durham, NC)
- …service. FUNCTIONAL EXPERTISE: Lead in the identification and implementation of process improvement projects, productivity initiatives and corrective actions ... distribution, HVAC/R, and utility generation equipment.Electrical & Automation system process improvement , design, and optimization experienceTechnical writing… more
- Merck & Co. (Durham, NC)
- …updating weekly metrics and deliverablesPromote a culture of continuous improvement and challenging the status quoComplete documentation of deviation eventsReview ... compliance from a maintenance perspective.Ownership of the Leader standardized work process which prioritizes resolution of issues from the shop floorCollaborate… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …(ie, problem solving, process mapping, value stream mapping and process confirmation) Identify, plan, implement identified improvement initiatives and ensure ... related tools Fulfills a key role in the SOP Expert Network, Process Workshops, & other document...in GMP processes, Quality Management System (QMS), & standard improvement systems preferred Demonstrated expertise in leading process… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …a plusKnowledgeable in core work processes & GMP concepts, knowledge of process improvement methodologies such as LEAN a plus Expert in change control, MS ... Tracks, GMP partners & Training partners on site. Expert in local change control process to support revision of standards. Interfaces with technical writers… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …efforts in Data Management and ensure global implementation.Promotes automation, innovation, process improvement and technology enhancement in Data Management to ... inspections. Finally, this position has advanced skills in continuous improvement , project management, change management, and risk managementResponsibilities: Leadership,… more
- Novo Nordisk Inc. (Durham, NC)
- …Utilize the appropriate cLEAN® tools within the main areas of Systematic Problem Solving, process improvement , & project management Serve as the Lead and SME to ... make what matters. The Position Serve as a Lead & Subject Matter Expert (SME) to provide technical expertise supporting site data and digitalization efforts.… more
- Merck & Co. (Durham, NC)
- …on time approval of payroll activities using site approved software like ADP. Process Execution / Continuous Improvement :Partner across the facility and ... support/awareness is given to issues as they ariseServe as a Subject Matter Expert during tours to provide area/ process overview information to visitors/auditors… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …while liaising with other functions including but not limited to Tech Support, Process Improvement , Validation, Supply Chain, Operations, QA, Reg CMC, and IT. ... cell therapy development and manufacturing.When necessary, support studies related to process improvement and implementation of new manufacturing execution… more
- Twist BioScience (South San Francisco, CA)
- …The Director will serve as the primary technical and strategic expert for all MES-related initiatives.Key ResponsibilitiesStrategic Leadership & Architecture: Define ... developers, analysts, and specialists, fostering a culture of continuous improvement , technical excellence, robust software development practices, and regulatory… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and may affect ability to achieve company goals. Pro-actively look for process improvement opportunities by challenging existing processes, proposing solutions, ... and cost-effective data and analysis. Viewed as a functional expert in this field by internal and external stakeholders....are well aligned and integrated into North American planning process , including any associated work streams. Ensure self and… more
- Merck & Co. (Rahway, NJ)
- …(CAPA) are effectively implemented.Primary Activities Serve as a subject matter expert for current good manufacturing practice (CGMP) requirements for vaccine and ... experience within the pharmaceutical, vaccine or medical device industry experience; Expert knowledge of GMP requirements for multiple regulatory agenciesExpert… more
- Merck & Co. (Rahway, NJ)
- …& Technology (DD&T) organization to serve as a senior technical subject matter- expert and advisor for our Autoinjector platform. This role's scope and accountability ... support for Autoinjector products, including performance monitoring, design optimization, and process validation. Additionally, coach and mentor others to grow their… more
- Eisai, Inc (NJ)
- …and globally. This role will identify, lead and participate in TMF system and process improvement initiatives, including SOP reviews, TMF reporting and serve as ... a subject matter expert in TMF Management.Will include but will not be...daily eTMF system related activitiesEnsure eTMF system and associated process align with ICH-GCP, regulatory and Eisai SOPsOversight of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …on implemented strategies' effectiveness and make data-driven recommendations for ongoing improvement . Continued Improvement : Cultivate a strong and supportive ... Experience within Nephrology preferred. Proven success in developing strategy through expert understanding of market and industry Ability to manage complexity,… more
- Merck & Co. (Durham, NC)
- …(CMO/CRO) to ensure uninterrupted supply of BCGCoordinate with analytical and process development groups to prepare for and coordinate analytical troubleshooting, ... in support of analytical procedure life cycle management.Act as subject matter expert informing development and optimization of existing analytical methods to enable… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …This role includes overseeing the marketing materials planning and review process , management of internal agency's operations, and facilitation of POA meetings. ... The leader will set clear goals and drive continuous improvement and innovation. This role actively participates as a...the status quo to ensure success Support the planning process to ensure AB anchoring of prioritized Marketing initiatives… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …management of the advertising agency and promotional review board (PRB) process to implement campaign elements, educational, promotional and public relations ... programs Monitoring, and Improvement Consistently assess brand performance, drivers and barriers of performance and execution of plans to maximize results Establish… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …management of the advertising agency and promotional review board (PRB) process to implement campaign elements, educational, promotional and public relations ... programs Monitoring, and Improvement Consistently assess brand performance, drivers and barriers of performance and execution of plans to maximize results Establish… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …experience team to inform future brand/therapy area strategy and objectives Continued Improvement o Cultivate a strong and supportive 'test and learn' team culture ... and they understand their level of accountability for results and the measurement process . Ensure that the IDP forms include completed learning and aspiration plans… more
