岗位职责:
1.负责跟进、落实制剂研发实验室的规划、设备物料及耗材的采购;规章制度、良好操作规范和5S的建设及监督执行。
Responsible to follow up implement the planning of DP R&D lab, procurement of equipment materials consumables; develop supervise rules regulations, good practices 5S implementation.
2.负责制剂处方的开发计划/方案及其他相关研究报告的起草/审核。
Responsible fthe drafting/review of formulation development plans/schemes other related research reports.
3.负责推进制剂处方工艺开发工作,包括早期成药性研究、临床制剂处方筛选、工艺优化、运输条件、稳定性考察等相关研究方案的制定、实施、评价、审核等工作。
Responsible fpromoting the development of formulation prescription process, including the development, implementation, evaluation review of early drug-forming studies, clinical formulation prescription screening, process optimization, transportation conditions, stability investigation other related research programs.
4.确保各项实验按照拟定的计划、方案执行;控制实验成本、进度和质量;审核实验记录。
Ensure that all experiments are executed according to the proposed plans protocols; control the cost, progress quality of experiments; review experimental records.
5.负责制剂项目管理、不断完善制剂研发平台。
Responsible fformulation project management continuous improvement of formulation R&D platform.
6.负责落实与制剂相关的IND申报资料和原始记录的整理、汇总和审核;配合药品注册现场检查。Responsible forganizing, summarizing reviewing informationiginal records related with DP fthe IND filing; cooperate with on-site inspection fdrug registration.
7.协助经理负责部门团队建设,以提升部门工作及业务效率和水平。
Assist the manager in team building to improve the work business efficiency level of the department.
8.根据部门职责及任务,协助经理安排部门内部的工作,指导下属制定并完成工作计划。
Assist the manager in arranging work within the department according to departmental responsibilities tasks, guide subordinates to develop complete work plans.
9.协助经理开展绩效考核:对直管下属进行绩效考核评估、绩效反馈沟通,指导制定绩效改进计划书。
Assist the manager in performance appraisal: Conduct performance appraisal assessment, performance feedback communication to directly supervised subordinates, guide the development of performance improvement plan.
任职要求:
1.本科或以上学历;化学、药学、制药工程、生命科学等相关专业。
College degree above; majin chemistry, pharmacy, pharmaceutical engineering, life science other related majors.
2.至少有三年制剂相关的工作经验;有一年团队管理经验;有国际知名药企工作经验的优先考虑。
At least three years working experience in formulation related field; one year team management experience; working experience in international well-known pharmaceutical companies is preferred.
3.了解生物药品制剂相关的GMP法规及指南;了解中国、ICH、欧盟及美国FDA法规对制剂行业的相关要求。
Knowledge of GMP regulations guidelines related to biopharmaceutical formulation; knowledge of China, ICH, EU US FDA regulations related to formulation industry requirements.
4.熟练使用各种办公软件 Proficiency in using various office software
5.具有良好的语言表达能力和书面写作能力;Good verbal written skills.
6.具有较强的计划、沟通和组织能力。 Strong planning, communicationganizational skills.
7.具有较强的抗压能力,工作积极主动。 Strong ability to resist stress work proactively.