- Merck & Co. (Durham, NC)
- …to improve the execution/review process for equipment.Develop training material. Working as a subject matter expert ( SME ), provide necessary training ... Job Description Position Description: The SME Associate Director, Electrical & Utilities Engineer is...systems regarding functionally of equipment and relied on as SME during regulatory discussions for Electrical and Automation and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …controls and maintain permanent inspection readiness and actively support regulatory inspections.Serves as Subject Matter Expert ( SME ) in preparation for ... root cause analysis, impact assessment, and CAPA/EC determination.Work cross functionally with SME 's and Quality to ensure robustness of investigations, as well as… more
- Merck & Co. (Durham, NC)
- …needed to ensure the right support/awareness is given to issues as they ariseServe as a Subject Matter Expert ( SME ) during tours to provide area/process ... overview information to visitors/auditors upon request.Working as a SME , provide necessary training for system maintenance as needed.Financial:Order and maintain… more
- Repligen (Clifton Park, NY)
- …programs, equipment optimization, vendor coordination, and quality support, while serving as a technical subject matter expert ( SME ) and team lead. The ... repairs across mechanical, electrical, pneumatic, hydraulic, and utility systems.Serve as SME for critical systems; guide troubleshooting and resolution of complex… more
- Insmed Incorporated (San Diego, CA)
- …and internal teams to troubleshoot and optimize platform performanceMedidata Rave Expertise:Serve as the subject matter expert ( SME ) for Medidata Rave, ... providing technical guidance and support to the teamReview software upgrades and database releases for impact to configurationsProvide support to DMs in creation of data listings using RAVE tools (eg, Business Objects, other) and non-RAVE tools/applications… more
- Merck & Co. (Rahway, NJ)
- …and make recommendations for actions.Project Management skills: Ability to serve as subject matter expert and lead multidisciplinary project ... bring about new technologies, digitization, and ways of working.Act as an SME for the evaluation of innovative equipment for optimizing manufacturing processes,… more
- Merck & Co. (Durham, NC)
- …to ensure the right support/awareness is given to issues as they arise-Serve as an Subject Matter Expert ( SME ) during tours to provide area/process ... overview information to visitors/auditors upon request-- Quality & Safety Compliance- Foster strong safety culture on the team through actions, coaching, and prioritization-Coach individuals when reporting safety issues and completing corrective/preventative… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …synthesize into a coherent risk management strategy.Represents the CSPV department as subject matter expert in cross-functional teams or committees ... regional level as required.Support audit and inspection readiness activities as a subject matter expert . This individual will be accountable for maintaining… more
- Lundbeck (Bothell, WA)
- …holders across the organization are key aspects of this role. The candidate will act as Subject Matter Expert ( SME ) in a technical capacity, manage ... outsourced cell line development activities, author relevant regulatory sections, collaboratively support cell culture development to optimize Lundbeck's platform process and function as Upstream representative in project teams. ESSENTIAL FUNCTIONS: Manage… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …EBR designs.Participate in design testing, release planning, and demos with partners.Serve as a Subject Matter Expert of MES for CAR-T and site initiatives ... Qualification Protocols) with alignment to Global Procedures.Act as a Site MES SME to support Quality Investigations, Corrections, and QMS records.Build the Site… more
- Merck & Co. (Millsboro, DE)
- …and preventative actions (CAPA) are effectively implemented.Primary Activities Serve as a subject matter expert for current good manufacturing practice ... (CGMP) requirements for vaccine and large molecule manufacturingPartner with our Company and CMO management to identify appropriate CAPA to address findings identified during audits and inspections. Monitor CAPA status and ensure CAPA are implemented in… more
- Merck & Co. (South San Francisco, CA)
- …and biomarker development.-Key Responsibilities:This is an individual contributor role as a subject matter expert responsible to implement data analytical ... tools and apply rigorous statistical methodologies to transform complex biomarker data into insights that can be readily used in drug development.Develop end-to-end data visualization tools and conduct spatial analyses to understand and interpret complex… more
- Merck & Co. (Rahway, NJ)
- …all GCP Regulatory Health Authority inspections, findings, responses and CAPAs, worldwide.Acts as the subject matter expert and primary point of contact for ... processes as well as quality management systems and quality control tools. Expert knowledge of GCP/ICH and worldwide Regulatory Health Authority requirements.Has… more
- Merck & Co. (Rahway, NJ)
- …syringes, and other drug delivery systems. The associate director will be a technical subject matter expert on the device components and combination products ... and lead a cross functional team members to support global commercialization and technology transfer activities and drive product robustness for sustained launch in alignment with the company's business goals, and quality and regulatory compliance.-Essential… more
- Merck & Co. (Durham, NC)
- …manufacturing and continuous improvement initiatives.ResponsibilitiesContribute technical expertise, and become a subject matter expert , in process and ... analytics to support end-to-end manufacturing science and technology for LVV products.Monitor site-specific and cross-site issues, help identify trends, and participate in the implementation of risk mitigation actions.Collaborate with functional teams to… more
- Merck & Co. (Durham, NC)
- …vaccine manufacturing and continuous improvement initiatives.ResponsibilitiesServe as a technical subject matter expert , providing end-to-end manufacturing ... science and technology support for LVV products.Monitor site-specific and cross-site issues, identify trends and participate in proactively implementing risk mitigation actions.Collaborate with functional teams to contribute to strategic workstreams, knowledge… more
- Eisai, Inc (Nutley, NJ)
- …company policies.Participate in review of CME grants.Serve as a medical leader and subject matter expert for relevant external (HCPs, strategic alliances ... sciences (PharmD, PhD, or MD) with substantial experience in the pharma/biotech industry.Deep subject matter expertise in relevant area along with a broad… more
- Merck & Co. (Rahway, NJ)
- …our Device Development & Technology (DD&T) organization to serve as a senior technical subject matter - expert and advisor for our Autoinjector platform. This ... of Autoinjectors and combination products.Primary Responsibilities:Technical Strategic Oversight:Provide deep subject matter expertise in the design, development,… more
- Novo Nordisk Inc. (WA)
- …with Enterprise Strategy. Manages relationships with select government agencies. Serves as a subject matter expert . Solicits internal stakeholder insights to ... analyze the business impact of select policy proposals - to NNI and the broader industry. Educates and enables broader PA Team and NNI business to leverage these positions. They lead and manage individual contributors in the Policy team, actively participate… more
- Merck & Co. (Rahway, NJ)
- …Director, Logistics and Distribution Technology will be responsible and accountable for subject matter expert technical support for distribution and ... effective shipping solutions to maintain temperature control and physical protection.Provide subject matter expertise and ensure scientific rigor, technical… more
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