Job Functions工作职责

Analysis Development分析开发

· Familiar with the establishment and optimization of large biomolecular HPLC/CE/Mass method;
熟悉结合活性、细胞活性方法的建立与优化及方法验证；

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

负责建立检测细胞库并参与细胞实验室的日常管理；

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

熟悉样品质量一致性评价中ADCC、CDC等表征工作，熟悉Protein A/HCP/HCD等残留方法的建立与优化，并建立平台检测方法；

· 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 bioscience 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。



Essential Experience必要经验

BS degree with a minimum of 0~3 years and MS degree with a minimum of 0~2 years of large Biomolecule analytical experience;

本科0~3年，硕士0~2年相关生物大分子分析经验；

· Mastered the theoretical knowledge of potency;

掌握生物效价的理论知识；

· Familiar with the literature retrieval and relevant information inspection, and familiar with the IND filing;

· 熟悉文献检索及相关信息检查，熟悉IND备案；

Strong communication and execution ability;

较强的沟通和执行能力；

Ability to bear certain stresses. Advanced computer system skills for Microsoft Office suite (Word, Excel, Powerpoint, Project, Outlook);

熟练使用Microsoft Office办公软件(Word、Excel、Powerpoint、Project、Outlook)。