Job Functions工作职责

熟悉生物大分子HPLC/CE/Mass方法的建立与优化；

· Familiar with HPLC/CE method validation in release inspection, and write method validation report after method validation;

熟悉放行检查中HPLC/CE方法的验证，并在方法验证完撰写方法验证报告；

· Prepare qualified samples to ensure the smooth operation of pre-clinical.

准备合格的样品，确保临床前的顺利进行；

· Draft the original experiment record and filing documents for IND.

为IND起草原始实验记录和归档文件；

· Experience in drug registration verification is a plus

具有药物注册申报核查的经历者优先考虑。

Qualifications任职资格

Major in Pharmaceutical analysis or related field;

药物分析或者其他相关专业。

Advanced post-graduate qualification (BS or MS) related to bioprocessing or biopharmaceutical production.

相关专业的本科或硕士学历。