• Merck & Co. (Rahway, NJ)
    …experience including computer system validation , System Life Cycle (SLC), software validation , and/or Quality Assurance functions.High level of expertise and ... of the Company's Research Laboratories Quality Assurance community, provide for and lead Quality Assurance oversight for computer system validation matters… more
    HireLifeScience (09/24/25)
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  • Merck & Co. (Rahway, NJ)
    …will play a crucial role in the supporting the development, analytical validation , and testing of histopathology-based assays for clinical implementation and ... following responsibilities: Engage in providing thorough histopathological reviews and testing clinical samples, leveraging expertise in disease processes and… more
    HireLifeScience (09/20/25)
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  • BioAgilytix (San Diego, CA)
    …life-saving therapeutics to the patients who need them.The Manager II will lead scientific and operational activities in support of preclinical, clinical, and ... You'll guide a team of scientists through assay development, validation , and sample analysis under GxP, while also playing...budgets and resources, and being the expert in using tools/ software relevant to the team.Work closely with clients to… more
    HireLifeScience (09/10/25)
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  • BioAgilytix (Durham, NC)
    …driving advancements that shape the future of healthcare.Essential Responsibilities:Independently lead assay development, validation , and sample analysis of ... In this role, you will take ownership of assay development, validation , and sample analysis using advanced chromatographic and mass spectrometric techniques.… more
    HireLifeScience (09/17/25)
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  • BioAgilytix (Durham, NC)
    …clear communication, and aligning project deliverables with client timelines and expectations. Lead assay development, validation , and sample analysis of ... best suited for someone with deep expertise in method development, GxP-compliant validation , and both targeted and untargeted analysis using chromatography and mass… more
    HireLifeScience (08/12/25)
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  • AUROBINDO (Durham, NC)
    … and technical review of documentation is required.Previous experience with reviewing software validation scripts and documents is preferred.Must be able to ... throughputSupport deplloyment of the electronic laboratory notebook system through training, validation script review, and validation protocols and reports.… more
    HireLifeScience (09/26/25)
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  • Insmed Incorporated (San Diego, CA)
    …Development teams, Regulatory Affairs, and external partners.ResponsibilitiesEDC System Design & Development: Lead the setup, development, and validation of EDC ... with regulatory requirements (eg, FDA, EMA, ICH-GCP) and company SOPsPerform user acceptance testing (UAT) and validation of EDC systems to ensure data integrity… more
    HireLifeScience (09/10/25)
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  • Legend Biotech USA, Inc. (Raritan, NJ)
    …MES updates with other Supply Chain Systems (ERP, eLIMs, etc.).Support MES validation activities according to the Software Development Lifecycle (eg ... of MSAT team reporting to the Manufacturing Execution Systems Lead and will be responsible for interfacing with MES...including but not limited to Tech Support, Process Improvement, Validation , Supply Chain, Operations, QA, Reg CMC, and IT.… more
    HireLifeScience (08/28/25)
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  • Legend Biotech USA, Inc. (Raritan, NJ)
    …with other Supply Chain Systems (ERP, eLIMs, etc.).Coordinate and execute MES validation activities according to the Software Development Lifecycle (eg ... be part of Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead and will be responsible for EBR development and administration at the… more
    HireLifeScience (07/04/25)
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  • Merck & Co. (Rahway, NJ)
    …have a solid knowledge of statistical methodology, experimental design, computing software and data management; a general understanding of worldwide regulatory ... trials and coordinating the statistical activities for clinical trial projects; and may lead a group of statistical or programming staff assigned to a development… more
    HireLifeScience (09/19/25)
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