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.
- 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.
- 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.