- Merck & Co. (Durham, NC)
- …(QMS), and Documentation Management.-Ensure compliance with all global and regulatory standards.Serve as the Subject Matter Expert ( SME ) for areas of ... certification. Significant experience in biologics, vaccines, and/or biopharmaceuticals compliance. Experience as Subject Matter Expert ( SME ) in… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …resources needed to make improvement to existing systems as needed. This role is the site Subject Matter Expert ( SME ) for site GMP Clean Utilities ... product and efficiency of operation. Responsibilities will include:Strong technical skills, be the Subject Matter Expert ( SME ) from equipment… more
- Merck & Co. (Durham, NC)
- …sponsor for the problem-solving efforts and solutions offered by other shifts and teams Subject Matter expert for LOTO and permit writing for maintenance ... team culture including significant interaction with Operations, Quality, Automation, Technology , and other groups as required. - Responsible for...given to issues as they arise Serve as a Subject Matter Expert during tours… more
- Merck & Co. (Durham, NC)
- …uptime, minimizing cost and maintaining process consistency.Develop training material. Working as a subject matter expert ( SME ), provide necessary ... complex troubleshooting and repairs of equipment, as well as supporting Technology and Quality during equipment investigations and modifications. The successful… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …product development and registration. The Director serves as a visible PED champion and subject matter expert within the US organization to execute PED ... portfolio and meet business and US needs Leverages novel digital health technology such as sensor/wearable data capture instruments to inform identification and/or… more
- Merck & Co. (Durham, NC)
- …actions. Over time, become a subject matter expert ( SME ) in specific process steps, automation technology platforms, and specific systems. Over time, ... becomes expert practitioner of structured problem solving and after-action reviews. Supports knowledge management and team learning to improve support of manufacturing processes. Coordinates projects with staff group for timely implementation of automation… more
- Merck & Co. (Rahway, NJ)
- …across functional areas to lead the development of novel drug delivery technologiesIs a recognized subject matter expert in at least one area of drug ... an enterprise levelStrong mentoring capabilities to build individuals and teamsRecognized as a subject matter expert in multiple drug delivery and/or… more
- Insmed Incorporated (San Diego, CA)
- …liaison with R&D on potency assay transfer into Analytical Development.Serve as a subject - matter - expert for cell-based potency assay cell line engineering, ... interactions (briefing books, etc) and filings (INDs/BLAs). Will act as a SME during interactions with health authorities.Define and implement state-of-the art … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …directly from sites/ Institutional Review Boards (IRBs), and other site personnel as neededStudy-specific subject matter expert ( SME ) for internal audit ... unmet medical needs of people globally by leveraging our world-class science and technology . With more than 125 years of scientific expertise and a presence in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …gather, document, implement and validate all system requirements for associated module(s).Serve as the Subject Matter Expert ( SME ) for respective modules ... unmet medical needs of people globally by leveraging our world-class science and technology . With more than 125 years of scientific expertise and a presence in… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …testing and release of product to patients in a cGXP environment.Key Responsibilities Acts as a subject matter expert ( SME ) for 21 CFR Parts 210, 211, ... we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and… more
- Merck & Co. (Rahway, NJ)
- …Team operations.-Adoption of portfolio and financial tools and processes. This includes becoming a subject matter expert that can host training to increase ... business case and guardrail management in collaboration with Business Technology Partners (BTPs) and Product Line Leaders (PLLs).-Tracking/Reporting Total Cost… more
- Genmab (Plainsboro, NJ)
- …of all documents and dossiers as applicable Proactively guide cross-functional teams as a subject matter expert to support submission strategyFor US based ... passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences,… more
- Merck & Co. (Rahway, NJ)
- …primary activities include and are not limited to the following: Function as a Subject Matter Expert on all power generation equipment and processes.Lead ... current and new technologies or approaches.Maintains an awareness of new technology and continually seeks application opportunities for new installations, existing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …linked to the objectives of the organization Client and Stakeholder Engagement Serve as a subject matter expert ( SME ) in event planning and execution, ... or live production setting required Prior hotel experience, working with scheduling technology as well as familiarity with event management software, (IE: Cvent,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …audits.Supports Quality risk assessment teams.Review/approve documents as a Quality on the Floor Subject Matter Expert ( SME ).Remain current in skills ... we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …documentation for compression upload Audits files to ensure compliance with process Serves as subject matter expert and point of contact for Service Now ... External relationships include but are not limited to Talent Acquisition technology vendors, background vendors, candidates and new hires. Essential Functions Offer… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …up to date knowledge of local, regional, and international PV regulations. Act as a subject matter expert in regulatory intel for PV and provides strategic ... unmet medical needs of people globally by leveraging our world-class science and technology . With more than 125 years of scientific expertise and a presence in… more
- Merck & Co. (Rahway, NJ)
- …and processes. Handle small projects as a lead analyst, project manager, or as the subject matter expert . Account and manage for the demands per region ... innovative IT team at our company, where we leverage technology to enable new organizational capabilities. We are seeking...via managing specific Order to cash process area or subject eg Order management, Customer Master. Based on our… more
- Twist BioScience (South San Francisco, CA)
- …closely with Internal Audit.Key Responsibilities:Act as a hands-on leader and SOX compliance subject matter expert who works with cross-functional process ... of SOX compliance professionals, including analysts, third-party service providers, and subject matter experts Provide strategic thinking, thought leadership,… more
