- Formation Bio (New York, NY)
- …GMP QA strategy and execution for Formation Bio's portfolio. Acting as the QA subject matter expert , this role supports CMC development activities, including ... of quality excellence, accountability, and continuous learning. Serve as the QA subject matter expert for all CMC-related quality activities and collaborate… 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
- Formation Bio (New York, NY)
- …a culture of quality excellence, accountability, and continuous learning. Serve as a subject matter expert on quality assurance matters during regulatory ... with requirements. About You Strategic and creative thinker, strong leader, and subject matter expert in pharmaceutical quality systems with the ability to… more
- Twist BioScience (South San Francisco, CA)
- …to meet business requirements 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… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …member of the Biostatistics and Data Management Data Operations team and serves both as a subject matter expert and leader of a group responsible for the ... role assignments in the Clinical Data Repository. Functional Expertise: Serve as a subject matter expert and provide oversight and technical support in the… more
- Genmab (Plainsboro, NJ)
- …and execution of a global medical communication and publication plan.Serve as the subject matter expert on publication-related matters establishing strong ... reviewing developed content, and ensuring process is consistent with Genmab SOPs.Bring subject matter expertise in discussions regarding the creation or updates… 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
- Merck & Co. (Rahway, NJ)
- …cost/size, number of trials, clinical trial design and Go/No Go decisions Serve 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Are you ready to make a difference? The Position The Medical Director serves as the subject matter expert for our products and related data within a ... Medical Directors, Marketing, and Market Access. External relationships include expert advisory board members, investigators, other consultants, and key customer… more
- AM General (Jensen Beach, FL)
- …maintenance programs, quality inspections, and warranty support in CONUS and OCONUS locations. As a Subject Matter Expert ( SME ), you will play an ... training programs. Instructor experience is a plus. Key Responsibilities Act as Subject Matter Expert on automotive systems including JLTV, trailers, and… more
- Merck & Co. (North Wales, PA)
- …across launch, in-line assets and indication management.Expertise in Analytics: Serve as a subject matter expert in marketing mix models, promotion ... decisions and enhance business performance.Collaborate: Work closely with stakeholders and expert analytics leaders to translate priorities into business needs and… more
- Merck & Co. (Rahway, NJ)
- …of the strategic elements of drug development and effective communication skills. As a subject matter expert , the Associate Director within the QP2-IO Group ... decisions on drug development teams. Primary Responsibilities: Serving as an expert representative for QP2-IO on Oncology clinical development teams. Framing… more
- Merck & Co. (Rahway, NJ)
- …of mentoring individuals in a peer-to-peer fashion and as a technical mentorRecognized as a subject matter expert in at least one drug delivery and/or ... to define a robust formulation and manufacturing processRecognized as a technical expert and scientific contributor with proven ability to identify and develop… more
- Merck & Co. (Lower Gwynedd, PA)
- …frameworks and guidances in collaboration with team leads. Serve as an internal subject matter expert on immunological background and laboratory aspects ... throughput, reduce turn-around times, and provide quality data. Providing expert technical representation on multidisciplinary teams will be expected.Responsibilities… more
- Merck & Co. (North Wales, PA)
- …in-process testing of Biologics Drug Substance (DS) and Drug Product (DP). - Act as subject matter expert ( SME ) across various franchises and analytical ... platforms. - Support biologics registrations, product launches, and troubleshooting activities. - Support compliance audits, inspection activities, and investigation/CAPAs . - - - Author and review technical documents. - Complete assigned work within… more
- Merck & Co. (North Wales, PA)
- …stability, and in-process testing of Biologics Drug Substance (DS) and Drug Product (DP).Act as subject matter expert ( SME ) across various franchises and ... analytical platforms.Support biologics registrations, product launches, and troubleshooting activities.Support compliance audits, inspection activities, and investigation/CAPAs.Author and review technical documents.Complete assigned work within established… more
- Insmed Incorporated (San Diego, CA)
- …a liaison with R&D for non-clinical/clinical biomarker LC-MS related needs.Serve as a subject - matter - expert for all HPLC and LC/MS based method development ... participate in CMC team and governance team activities as an SME .ResponsibilitiesThe Senior Scientist will specialize in LC/MS-based analytical development for large… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …consultation on inter-site projects & 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 of all SAP SCM functionality Creates transparency in the Supply Chain by developing metrics & monitoring systems to track, analyze & improve SAP SCM Master Data quality, Transaction Data timeliness & adherence to… more
- Genmab (Plainsboro, NJ)
- …and leading competency development.Lead functional working groups; serve as process owner or Subject Matter Expert ( SME ) within Clinical ... Operations.Support training initiatives across Trial Operations as needed.Trial support: Take on GCTM tasks when necessary to support trial execution, including setup of new protocol amendments, ad hoc data cuts, or temporary coverage.Provide strategic support… more
- Tris Pharma (Monmouth Junction, NJ)
- …reporting, cost reporting, audit coordination, grant management, regulatory compliance, etc.; Serves as Subject Matter Expert ( SME ) and advisor to ... President/CEO and Senior Leadership team including insights on financial performance, capital allocation, and risk management; Directs cost monitoring and reporting activities; Drives financial planning, budgeting and regularly monitors and reports on company… more
