- Insight Global (Sanford, NC)
- …Description Our pharmaceutical client is seeking a highly skilled and experienced Senior Method Transfer and Validation Scientist to join our team. The ... candidate will have a strong background in analytical chemistry, specifically in method transfer and validation . This role will involve overseeing and… more
- Merck (West Point, PA)
- …Knowledge | Skills** + Knowledge of ICH, USP and other compendial chapters required for method transfer and validation . + Knowledge with late-stage method ... validation , and life-cycle management of methods but mainly global method transfer activities. Within the Global Quality Large Molecule Analytical… more
- ThermoFisher Scientific (Middleton, WI)
- …Assists with quality systems and new equipment. + Assists in designing method validation or method transfer protocols and establish project timelines. + ... of the project and communication of regulatory issues with senior level team members. **A day in the Life:**...members. **A day in the Life:** + Independently performs method validations, method transfers and analytical testing… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …the incumbent will perform or assist in the following: 1. Biochemistry test method development, validation , transfer , and replacement 2. Assay ... troubleshooting 3. Instrument Qualification 4. ICH test method validation status of test methods, and...agencies. The incumbent will assist in the replacement or transfer of test methods for improving assay performance and… more
- Amgen (Thousand Oaks, CA)
- …group is responsible for early phase analytical development, including method development, method validation , method transfer , process and product ... USP monographs and chapters, and ICH/FDA guidance documents related to analytical method transfer and validation , impurities, mutagenic impurities, early… more
- Gilead Sciences, Inc. (La Verne, CA)
- …and mitigation plans as needed + Review and approve biological test methods and method validation / transfer reports + Review and approve lab investigations ... a highly motivated individual to join us as a Sr . QA Specialist for the Gilead La Verne Quality...associated with release testing and method validation / transfer at the site… more
- Actalent (Bothell, WA)
- …of cell therapy products + Maintenance of human cell lines + Creation of test method transfer and validation protocols + Authoring of test methods and ... AND RESPONSIBILITIES: + Work cross-functionally with AD in the transfer and qualification of the cell-based test methods +...deviations, CAPAs KNOWLEDGE, SKILLS AND ABILITIES: + Execution of method validation in a commercial facility +… more
- Lilly (Indianapolis, IN)
- …observations, deviations, analytical investigations, change controls, equipment qualifications, computer systems validation , method validation , transfer ... Global Quality Analytical & QC Operations (AQCO) team is also growing. The Sr Principal - Business Quality Assurance (BQA) ensures laboratory activities conducted by… more
- Lilly (Indianapolis, IN)
- …of custody to meet regulatory compliance for data integrity. Automate workflows for method transfer , validation , and data integrity compliance. 3. Disruptive ... its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. \#WeAreLilly more
- Endo International (Rochester, MI)
- …analytical testing requirements of commercial/pre-commercial materials and products, including method development, validation and transfer , ... + Evaluates, troubleshoots/improves existing analytical methods when necessary + Prepares method validation protocols, reports, analytical test methods, and… more