- Novo Nordisk Inc. (Durham, NC)
- …materials, deviations, change controls, review & approval of SOPs, QA presence & process confirmation on shop floor & improvement of Quality processes on ... Regulations, ISOISP standards, corporate & local SOPs Lead improvement activities/ improvement of standards within the assigned process Provide coaching to… more
- Novo Nordisk Inc. (Durham, NC)
- …materials, deviations, change controls, review & approval of SOPs, QA presence & process confirmation on shop floor & improvement of Quality processes. ... Regulations, ISOISP standards, corporate & local SOPs Leads improvement activities/ improvement of standards within the assigned process Provides coaching to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the clinical trial portfolio. Assists in creating, leading & delivering upon complex improvement /innovation projects for CDO and/or as part of a global team and as ... external partners relevant to the design & implementation of clinical trials improvement /innovation projects for CDO & Novo Nordisk (eg Investigators and site staff,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …partners relevant to the strategy, design & implementation of clinical trials improvement /innovation projects for NACD & Novo Nordisk (eg Investigators and site ... stakeholders relevant to the strategy, design & implementation of clinical trials improvement /innovation projects for NACD & Novo Nordisk (eg, across NACD, CMR,… more
- Merck & Co. (Rahway, NJ)
- …ADCs, fusion proteins, combinations such as doublet or triplet co-formulationsSubject matter expert of process development and process characterization for ... Our development teams ensure robust composition, primary packaging/device, and process selection through deep fundamental understanding and characterization such… more
- Merck & Co. (Rahway, NJ)
- …to multitask, prioritize tasks, and meet tight deadlines. - Continuous Improvement Mindset: Proactive approach to identify process inefficiencies, develop ... The incumbent must have demonstrated understanding of E2E product development process & connectivity between functions supporting pipeline (ie clinical development,… more
- Merck & Co. (Durham, NC)
- …plants with a "Safety First, Quality Always" mindset striving for continuous improvement . We work in the local plant connected to our global manufacturing ... are not limited to: Project Support: Supports project team as operations expert through start-up, commissioning, qualification through licensure and ramp up of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …via the following responsibilities / activities: Leading / contributing to process improvement initiatives Ensuring streamlined and efficient communication ... manner Budget management and oversight of contract-to-purchase order (PO) process Facilitating key meetings (internal GMA, cross-functional, cross-regional, vendor… more
- Merck & Co. (Durham, NC)
- …manufacturing plants with a "Safety First, Quality Always" mindset, striving for continuous improvement , and earn our right to produce. We work in local plants ... are not limited to; Project Support Supports project team as operations expert through start-up, commissioning, qualification through licensure and ramp up of… 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
- Merck & Co. (Durham, NC)
- …plants with a "Safety First, Quality Always" mindset striving for continuous improvement . We work in the local plant connected to our global manufacturing ... interpersonal, communication, and collaboration skills responsible for supporting the manufacturing process . Individual will possess the ability to lead a small… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …drug regulators.Demonstrated understanding of quality management and continuous process improvement principles including global cGMP requirements.Expertise ... resolution manner in appropriate way and to ensure continuous improvement in the management of CMO risks. Interacts with...teams and will partner closely with other Subject Matters Expert across all the Functional Units (Global ADC Team… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …organizationsMust have solid understanding of quality management and continuous process improvement principles including global cGMP requirements.Experience with ... resolution manner in appropriate way and to ensure continuous improvement in the management of CMO risks. Interacts with...teams and will partner closely with other Subject Matters Expert across all the Functional Units (Global ADC Team… more
- Merck & Co. (Rahway, NJ)
- …ensure compliance and reduction in workplace safety risks.Lead global continuous improvement initiatives to improve global safety programs.-Build safety and EHS ... safety performance, strengthen compliance and further minimize safety risks.Provide support and expert advice to divisions and sites to control safety hazards for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …external data oversight plan, and guidelines. Operational Efficiency / Continuous Improvement : Identify opportunities for continuous process and technology ... Operations team and serves both as a subject matter expert and leader of a group responsible for the...data access requests, procedures for the periodic review, and process improvements. This position will also work with members… more
- Merck & Co. (Durham, NC)
- …exciting facility will have the unique opportunity to give input in the design process , startup their areas, and lead the teams to full production.Our ability to ... FridayPosition Responsibilities: Project Support Supports project team as operations expert through start-up, commissioning, qualification through licensure and ramp… more
- Twist BioScience (South San Francisco, CA)
- …and work with users to gain UAT sign-off.Serve as the subject matter expert for key SAP FI/CO modules and processes.Serve as the technical subject matter ... expert for Finance processes.Provide application support, identifying and implementing approved corrective and preventative actions in continuous improvement … more
- Merck & Co. (Rahway, NJ)
- …and work proactively with IT on data issues as part of daily reconciliation process ; Check the accuracy of the master and operational data which impacts dashboard ... reports and dashboards to assist the business Serve as a subject matter expert .Remain current on new features and functionality of the Spotfire product line and… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …You will be setting priorities, forecasting, and identifying resources needed to make improvement to existing systems as needed. This role is the site Subject Matter ... Expert (SME) for site GMP Clean Utilities infrastructure and...infrastructure and systems (WFI, Clean Steam, Pharmaceutical/Oil-Free Compressed Air, Process Gases, HVAC, etc.) and applications in aseptic manufacturing.… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …& is considered to be SAP Supply Chain Management (SAP SCM) Subject Matter Expert (SME) at API M2-US. Serves as local lead regarding the development & maintenance ... and MES systems are optimized & fit for purpose Identifies SAP SCM system/ process gaps & develops proposals for future requirements to mitigate them Tests SAP… more
