- Endo International (Rochester, MI)
- …and approves laboratory test data and documentation (eg notebooks, raw data and technical documentation, test method, validation protocol, or validation ... requirements of commercial/pre-commercial materials and products, including method development, validation and transfer, pre-commercial/commercial testing of materials and samples… more
- Eisai, Inc (Exton, PA)
- …release and stability testing activities; direct product characterization and assay validation . The individual may be required to perform hands-on testing in ... release and stability testing activities; direct product characterization and assay validation . The individual may be required to perform hands-on testing in… more
- BioAgilytix (Durham, NC)
- …best suited for someone with deep expertise in method development, GxP-compliant validation , and both targeted and untargeted analysis using chromatography and mass ... budget, and revenue management.Act as primary client contact, presenting data , ensuring clear communication, and aligning project deliverables with client… more
- AUROBINDO (Durham, NC)
- …for study types ranging from reverse engineering to method development/ validation to product characterization.. Drafts protocols and performs experiments ... independently with some guidance from Director. Organizes and presents data to support and document product development decisions. Leads investigations to support… more
- Applied Research Solutions (San Antonio, TX)
- …work. + Performing initial reviews of test result and uploading output data to appropriate repositories. + Troubleshooting when validation platforms fail ... network design + Conducting engineering tests and troubleshooting on server validation platforms. + Technical functions in support of engineering + Experimental… more
- BioAgilytix (San Diego, CA)
- …and execute validation and sample analysis plansReview and evaluate PK/TK data and ISR results to identify trends and outliersPlan and execute cross-site ... and metabolite profiling/ID. You'll guide a team of scientists through assay development, validation , and sample analysis under GxP, while also playing a key role in… more
- Insmed Incorporated (San Diego, CA)
- …(eg, FDA, EMA, ICH-GCP) and company SOPs.Perform user acceptance testing (UAT) and validation of EDC systems to ensure data integrity and accuracy.Implement and ... development and implementation of EDC systems to support clinical trials, ensuring data quality, compliance, and efficiency throughout the study lifecycle. The AD,… more
- Genmab (NJ)
- …discussionsActs as a role modelEnsures consistency of statistical methods and data handling across trialsEnsures all compound/indication related work and information ... analysis plans, results meetings presentations and clinical trial reportsCoordinate data transfers from/to business partners in collaboration with the programmer… more
- Merck & Co. (Rahway, NJ)
- …across the assembly and packaging platform portfolio, including interrogation of the data / science through technical reviews and exploring alternative ways to view ... transfers across the network inclusive of aligning the control and validation strategies. Minimum Education Requirements and Experience: Bachelor of Science (BS)… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … and reporting requirements and aligns tools/models/reportingWorks in collaboration with Validation function to established global tiered data governance ... global MSAT (GMSAT) organization. This individual will be part of the statistics and data science team in GMSAT that is responsible for all applied statistics and… more
