- Merck & Co. (Rahway, NJ)
- …cutting-edge drug delivery device technologies and their potential applications to the our Company pipeline. This will include freedom to operate (FTO) and ... intellectual property (IP) considerations in collaboration with the Legal department.Lead early feasibility/development studies to determine viability and inform on technology selection and development strategies. This includes, but not limited to, design for… 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 ... efficiency of operation. Responsibilities will include:Strong technical skills, be the Subject Matter Expert ( SME ) from equipment Utilities-HVAC systems.… 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, ... other departments or outside contractors/vendors to complete tasks.Acts as an SME for internal and external agency inspections.Supports technical and quality… more
- Merck & Co. (Durham, NC)
- …prevent recurrence including the development and implementation of corrective 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… 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. (Durham, NC)
- …uptime, minimizing cost and maintaining process consistency.Develop training material. Working as a subject matter expert ( SME ), provide necessary ... training for system maintenance.Work alongside operations and lean six sigma team members to develop reliable, consistent manufacturing processes that meet cGMP requirements.Support safety programs (LOTO, HECP, etc.) and environmental compliance from a… 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, ... (briefing books, etc) and filings (INDs/BLAs). Will act as a SME during interactions with health authorities.Define and implement state-of-the art technology… 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 ... or Health Authority (HA) questions related to medical monitoringFor studies in which Medical Monitoring activities are conducted by the Contract Research Organization (CRO) Medical Monitor (MM):Provides oversight to the CRO MM for clinical data review… 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 ... end-user experience.Responsibilities- HR Systems ManagementAct as the principal functional expert and advisor for implementation and ongoing management and… more
- Novo Nordisk Inc. (WA)
- …intellectual property. Manages relationships with select government agencies. Serves as a subject matter expert . Solicits internal stakeholder insights to ... to NNI. Essential Functions Achieve deep understanding of, and serve as a subject matter expert on, assigned policy areas and the potential impact to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …access trends, hub program utilization, and performance against defined KPIs Function as subject matter expert on patient reimbursement support services and ... collaborate cross functionally within the commercial organization to design and implement programs that support the company's patient support objectives for inline and launching brands Champion integrated approach across teams to provide a best-in-class… more
- Merck & Co. (Rahway, NJ)
- …cost/size, number of trials, clinical trial design and Go/No Go decisionsServe as a subject matter expert and foster collaboration within QP2 and across ... the above duties and to develop the above capabilitiesLeverage significant pharmacometric and subject matter expertise in a broad range of therapeutic areas,… more
- Merck & Co. (Rahway, NJ)
- …requiring highly organized data collection and management Primary Responsibilities: Serve as the subject matter expert in cell line development and technical ... lead to represent functional area for biologic pipeline programsWork independently, including proactive planning, trouble shooting and successful execution of complex experimental protocols for cell line developmentComplete and effectively manage multiple… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …laboratory equipment and supplies. Additional duties may include acting as an internal subject matter expert and limited scope client interaction to ... assist management or director study with execution or resolution of study issues. The Laboratory Supervisor may review, perform quality control correct and give guidance to director reports. The laboratory supervisor may author or co-author methods, SOP's and… more
- Merck & Co. (South San Francisco, CA)
- …science and/or new modalities.-Lead cross-functional scientific due diligence teams. Integrate internal subject matter expert input to build strategic ... rationale and internal support for business development opportunities.- Prepare slides and materials for presentation of partnering opportunities to our Company's R&D leadership for approval.-Conduct competitive landscape analysis to help guide business… more
- Merck & Co. (Rahway, NJ)
- …employees can thrive. Responsibilities include but are not limited to: Act as a subject matter expert in process development and characterization of ... ideal candidate for this position should be a recognized expert in the field, with demonstrated expertise in process...team members. Partner with functional area project teams and subject matter experts to establish and implement… more
- Merck & Co. (Rahway, NJ)
- …and global Technical and Quality Agreements, Participating in contractor GMP audits as a Subject Matter Expert , Conduct of contractor "deep dive" quality ... assessments such in data integrity and leading cross-functional contractor performance reviews as the quality lead for the oversight platform, Supporting product development teams in outsourcing activities to enable our diverse pipeline Serving as the bridge… more
- Merck & Co. (Rahway, NJ)
- …based on priorities and assesses the impact of bi-annual system updates. Serves as subject matter expert to consult with end-users on appropriate system ... processes and procedures.Participates in projects and programs where functional processes are impacted, inclusive of mergers, acquisitions, and divestituresPartners with the solution leads, global centers of excellence and IT to enable the evolving technology… more
- Merck & Co. (Durham, NC)
- …to FDA associated with Product Quality Complaint, or site Significant DeviationsServes as Subject Matter Expert for areas of responsibilityDirect support of ... regulatory inspections and audits, including presentation/defense of Complaints/Adverse Events system during regulatory inspectionsResponsible for identification of trends, ongoing monitoring of the system, and providing recommendations for continuous… more
- Merck & Co. (Rahway, NJ)
- …topic discussion)Review area alarms and log completions to ensure compliance.Serve as an Subject Matter Expert to provide area/process overview information ... to visitors/auditors upon requestProvide a leadership presence on the packaging floor.Champion standard work to drive consistent use of best practices.Represent Operations on project teams as needed.Ensure a culture of inclusion and consistency is maintained,… more
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