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Recruit Analytical Principle Associate - New Drug Early Discovery
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Job Description: • Analytical method development & validation, in-process-control, starting materials quality control, intermediates and impurity profiling and identification, specification establishment, batch release testing, technical report & document preparation, etc.. • Provide analytical support to process and formulation • Coordinate the technology transfer of analytical package and support the manufacturing of API and formulation externally. • Identify and troubleshoot technical issues. • Accurately record original data and be able to interpret and present the results. • Write/co-author documents and scientific reports, including analytical development report in support of regulatory submissions. • Collaborate closely with process chemist to establish specifications of IPC steps and final API release. • Design and conduct the stability study for drug substance and drug product in accordance with established methods and specifications. • Actively participate in analytical team efforts and contribute to technical evaluations and solutions. • Train and coach junior analytical scientists. • Maintain the proper operation of HPLC, LC-MS and GC-MS instruments and know some basic troubleshoot. Job Requirements: Education/Qualifications教育程度/所获资格证书 • Master degree in Pharmaceutical Analysis/Analytical Chemistry/Pharmaceutical Science or other related majors with at least 5 years’ working experience in pharmaceutical analysis or related area. • Or Ph.D. degree with 1~2 years’ working experience in pharmaceutical analysis or related area. Leadership Competencies领导者胜任力 Job Required Competencies岗位所需胜任力 • Solid knowledge on the state-of-the-art analytical technologies, and hands-on experience in operating, calibrating, maintaining and troubleshooting of a wide range of instruments (HPLC, GC, LC-MS, GC-MS, UPLC, UPLC-MS, KF, UV, IR, PSD, Dissolution apparatus, etc.). • Be proficient to analytical method development and validation for API and pre-clinical formulation release, stability study, in-process-control, quality control of starting materials and impurity profiling. • Familiar with regulatory guidelines such as ICH, FDA, EMEA, and SFDA. Experience with protocol and report drafting and reviewing. • Experience in analytical support for large molecules and peptides will be a plus. • Good written and oral English are expected. • Excellent communication, interpersonal skills and team-working ability is required. |
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zjutwangdong
新虫 (正式写手)
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2楼2015-06-16 22:08:45
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