职位描述
Responsibilities:
Participate in innovative solutions with limited instructions for some common DP problems, as intermediate individual contributor, finish some common DP development work, contribute to the DP platform of the company and DP project development. 在有限的指导下参与创新解决方案，以解决一些常规制剂相关问题，作为中级技能个人贡献者，独立完成一些常规制剂开发相关工作，对公司制剂技术平台的改进和制剂项目开发有作用。
1. Innovative DP tech work 创新分析技术工作
- Participate in innovative solutions with instructions for some common DP problems, contribute to the DP platform of the company.在有限的指导下参与创新解决方案以解决一些常规制剂相关问题，对公司制剂技术平台的改进有作用。
- Know most of the latest tech in DP field with instructions.
在指导下对最新制剂技术广泛了解。 Participate in deviation and change control from MFG/QC.
- 参与生产和QC的偏差和变更技术评估。
2. Operating DP work 日常制剂工作
- Have some tech skills of DP development (including formulation, DP process), as intermediate individual contributor, finish routine DP development work independently, including one of injection, lyo, PFS..
具备制剂开发领域的一些常用技术技能（包括处方和制剂工艺），作为中级技能个人贡献者，独立完成日常制剂技术工作(包括西林瓶注射液，冻干，预充针中的一种剂型）。
- Participate in small and medium-size projects as organization members, independently perform DP development work with limited instructions.
可以参与中小型项目，在有限的指导下独立进行制剂相关工作。
- Communicate with PD, MF, QA, QC, RA and outsourced partners to finish the relevant DP work of projects.
与PD内部、生产、QA、QC、RA等部门沟通，与公司外部客户等沟通，顺利完成各个项目的开发工作。
- Know about some of DP parts in regulations, USP/EP/CP, ICH guidelines.
了解法规，药典，guidelines制剂相关部分内容。
3. Project management work 项目管理工作
- Instruct and review lower-level colleagues in DP development work. 指导和审核下级专业人员的制剂开发工作。
- Help to coordinate projects, and review the work result of others within work area. 在工作区域内帮助协调项目，并审查其他人的工作成果。
Qualifications Required:
1. College or above degree in Biochemistry, Analytical chemistry, Bioengineering, Pharmacy, etc. 本科及以上学历，具有生物化学、分析化学、生物工程、药学等相关专业背景
2. For MS, at least 1-year DP experience in biopharmaceutical. For BS, at least 3-year DP experience in biopharmaceutical. 硕士需要至少1年生物制药行业制剂工作经验。本科需要至少3年生物制药行业制剂工作经验。 本科需要至少3年生物制药行业制剂工作经验。
3. Have some tech skills of DP development （including formulation, PPM, DP process）, as intermediate individual contributor, finish routine DP development work independently, including one of injection, lyo, PFS. 具备制剂开发领域的一些常用技术技能（包括处方和制剂工艺），作为中级技能个人贡献者，独立完成实验室日常制剂技术工作(包括西林瓶注射液，冻干，预充针一种剂型）。
4. Proficient in some quality analytical methods in DP development, such as MFI, DLS, visual inspection, viscosity, etc. 熟悉制剂开发的一些质量分析方法，如MFI、DLS、visual inspection、viscosity等。
5. Strong ability of trouble shooting in some common DP problems with limited instructions. 在有限的指导下很强的解决一些制剂方面常规问题的能力。
6. Know about DP parts in regulations, USP/EP/CP, ICH guidelines. 了解法规，药典，guidelines制剂相关内容。
7. Show strong willingness to work closely with peers within and outside the team toward a common goal. 团队内部和外部的人员进行积极有效的沟通。
8. Good English and good computer skill 英语水平良好，熟练使用电脑