职责概要：全面负责苏州工厂工艺开发部门制剂部分的研发工作。



岗位职责：



1、从事生物制剂处方工艺研究工作，负责制剂处方筛选、工艺路线的研究及确定。



2、组织和计划制剂工艺的优化流程和中试放大生产的协调工作。



3、主导或参与技术转移工作。



4、负责生物药注册制剂研究部分资料的撰写与审核。



任职资格：



1、硕士学历，药学、药剂学、生物等相关专业。



2、具备药物制剂的理论知识和实践能力。有生物制剂开发经验者优先。



3、熟悉国内外现行药典，熟悉NMPA，FDA, EMA, ICH 等权威机构的指导原则，有撰写新药申报（IND, BLA）经验者优先。



4、工作积极主动、服从安排，沟通能力强，有思考解决问题能力和良好的团队精神。






Position: FD Engineer



Location: Suzhou



Job Summary:



The candidate will be responsible for FD in Suzhou site.



Responsibility：



1．Engaged in the DP formulation research of biopharmaceutical, Responsible for DP formulation screening, process route research and determination.



2．Organize and plan the DP process optimization, and coordinate the pilot scale-up production.



3．Lead or participate in technology transfer.



4．Responsible for material compiling and examining of DP research on biopharmaceutical registration.



Qualification:



1．Master degree in pharmacy, biology or related fields.



2．Proficient in pharmaceutical DP theory and practice. Experience in biopharmaceutical DP development is preferred.



3．Familiar with the current Chinese and foreign Pharmacopoeia, familiar with the guidelines of authoritative institutions such as NMPA, FDA, EMA, ICH, etc. Experience in new drug declaration (IND, BLA) is preferred.



4. Active, obedient, strong communication skills, good at thinking and problem-solving, good team spirit.