ScientistReq # JR - 024395 Location Suzhou, Jiangsu, China Additional Locations 40 Job Category Research and Development Date posted 07/29/2020
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Essential Duties and Responsibilities. This section contains a list of five to eight primary responsibilities of the work. The incumbent will perform other duties as assigned.
Develop and validate analytical methods based on ChP, USP and ICH requirements. Work closely with stability study director to support stability study as analytical lead and prepare analytical related CTD dossier if needed. Investigate any suspicious data (unscientific, OOT and OOS). Maintenance and calibration of laboratory equipment. Ensure proper handling, storage and disposal of all chemicals used in the lab. Follow laboratory safety rules, regulations and standard operating procedures required for the task assigned. Support in audit preparation. Transfer method to manufacture plant and provide method training if needed. Prepare protocols, reports, and necessary SOPs. Conduct studies using state-of-the-art instrumentations including GC/MS, LC/MS, ICP and various general chemical tests. Having an in-depth knowledge and understanding of GLP/GMP and related regulations and guidance.
Qualifications. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required.
N/A: Intern or Co-op
Extensive experience in analytical chemistry and solid knowledge of quality systems. Good knowledge in stability design and test. Familiar with many state-of-the-art analytical instruments including GC, LC, and ICP-MS. Ability to interpret results from complex instrumentation and scientific studies. Good computer skills, experience with modern electronic systems like LIMS and ELN is preferred. Good communication skills; able to communicate effectively in both written and verbal manner. Good English skills in both writing and speaking.
Education and/or Experience. Include the education and/or experience that is necessary to perform the job satisfactorily.
N/A: Intern or Co-op
1. MS with a major in chemistry, pharmaceutics, material and polymer sciences scientific discipline with at least 4~6 years of experience or BS with more than 7 years relevant experience.
2. GMP experiences in pharmaceutical industry would be preferred.
3. Familiar with international/local regulation and guidelines.
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