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Senior Research Scientist I or II in Analytical Development

1 month ago

Cranbury, United States J-STAR Research Full time

J-STAR Research, Inc. operates as a contract research organization for pharmaceutical and biotechnology companies worldwide. It offers services in the areas of custom synthesis/contract research, process and analytical research, cGMP synthesis, crystallization process development, solid form screening and selection, pre/early formulation, and drug substance-drug product coprocessing. Responsibilities: Develop analytical methods and conduct the method validation. Ensure that methods are adequately documented, and that protocols and reports are correct and complete. Conduct release testing for GMP raw materials, intermediates and final APIs. Review test data to ensure completion and accuracy. Troubleshoot and maintain analytical instruments. Write SOPs, protocols, and reports as needed. Train QC/AD and other applicable personnel on department procedures and test methods. Conduct OOS and deviation investigations, as needed. Support Quality Assurance as needed during internal audits and audits by clients and regulatory agencies. Assist in the development and implementation of corrective actions related to QC/AD. Supervise quality control on API and/or intermediate within cGMP environment. Supervise analytical method development and validation. Supervise analytical support to the R&D chemists Help ensure that client project needs, requirements, and timelines are communicated to the QC/AD group. Work with clients to develop or transfer test methods for materials used or supplied by J‑STAR. Requirement Qualifications: MS or PhD in Chemistry, Pharmaceutical Science or related field. 0-5 years of experience in analytical development and quality control Good understanding of analytical chemistry and organic chemistry of small molecule drug substances. Hands-on experience on HPLC/UV, LC/MS, MS, NMR, and other analytical instrument Strong communication, organization, and planning skills. #J-18808-Ljbffr