职位描述：
职责描述 1.领导制剂团队对候选生物药分子的物理和化学性质进行评估，筛选开发制剂； 2.领导开发制备用于临床的制剂处方和工艺； 3.负责领导制剂工艺开发团队，安排团队的日常工作，对下属员工进行培训,保持团队高效的工作； 4.能快速探索新技术，成长为相关的领域的技术领导者； 5.负责撰写技术报告，准备CFDA、FDA相关的申报资料； 6.配合生产部门做好技术转移和放大工作； 7.领导项目和安排团队会议并协调项目团队中日常工作。 Key Responsibilities 1.Lead formulation team to evaluate the physical and chemical properties of biologic candidate molecules, and to screen agents for formulation development of biologics. 2.Lead to develop prescriptions and techniques for clinical trial. 3.Responsible for management and productivity of the formulation team. 4.Quick adapt to new technology and be a technical leader in formulation-related areas. 5.Write technical project reports and prepare document for cFDA and FDA IND filling. 6.Work closely with production team for tech transfer and scaling up. 7.Lead project and matrix team meetings and coordinate activities within the project teams. 任职要求 1.生物、化学、制药等相关专业硕士及以上学历； 2.3年以上生物制药或生物技术行业的工作经验； 3.对生物制药制剂配方有深刻认识； 4.熟悉工艺放大和工艺转移相关工作流程； 5.熟悉cGMP及ICH指导原则的优先考虑； 6.具有良好的沟通和协调能力、优秀的团队合作精神和良好的职业素养。 Requirements 1.M.S. or above in Biology, Chemistry, Pharmaceutical Sciences, Chemical Engineering or a closely related field. 2.3+ years’ experience in the biopharmaceutical or biotech industry. 3.In-depth knowledge of biopharmaceuticals formulation principles. 4.Working knowledge of process scale-up and technology transfer. 5.Knowledge in GMPs, ICH guidelines is preferred. 6.Excellent communication skills both in writing and oral presentation. 7.Excellence in organizational, interpersonal, communication skills and with strong problem-solving capability. 举报