[武汉]鼎康（武汉）生物医药有限公司

职位描述：
1. 带领并参与生物药物的制剂和药品灌装的工艺开发及稳定性评估活动，如
单克隆抗体,双特异性抗体,重组蛋白等；
Lead and participate in formulation and drug product (DP) process development and stability assessment activities for biological drugs, such as monoclonal antibody(mAb), bispecific antibodies, recombinant proteins, etc;
2.根据国内外药物质量要求和GMP要求，根据对治疗药物的全面理化知识，独立筛选和优化不同剂型的制剂和药物生产工艺；
Independently screen and optimize the formulation and drug product process of different dosage forms based on a comprehensive physicochemical knowledge of therapeutic drugs according to domestic and international quality requirements and GMP requirements;
3. 建立从中试到商业化规模的药品生产流程；
Establish drug product process from pilot scale to commercial scale;
4. 针对不同阶段的不同产品制定稳定性的程序；
Develop the stability program for different products, in different stages;
5. 开发适用的分析方法，用以支持生物物理表征，配方和工艺开发及研究稳定性的测试；
Develop fit-for-purpose analytical methods to support biophysical characterization, formulation and process development, and research stability testing;
6. 按照有关规定进行配方研究，制作有关原始记录，整理和归档数据，协助和参与申报数据的编制；
Conduct formulation research and make relevant original records according to relevant specifications, organize and file data, assist and participate in the preparation of declaration data;
7. 应按照SOP进行配方设备的实验室维护、校准、操作和维护；
Laboratory maintenance, calibration, operation and maintenance of formulation equipment shall be carried out and operated according to SOP;
8. 与有关部门紧密合作，确保项目顺利进行；
Work closely with relevant departments to ensure the smooth progress of the project;
9. 领导安排的其他相关工作。
Other related work arranged by line Head.