岗位职责:
1.Responsible for DP MSAT management, organizing and carrying out MSAT activities in accordance with the technology transfer management protocols to continuously improve DP MSAT system.
2.Responsible for formulating DP MSAT strategy and timeline, coordinating the progress and handover between R&D and production, and ensuring reasonable stage process development and technology transfer; coordinate to solve problems in the process of technology transfer.
3.Review DP MSAT related documents such as: gap analysis and risk assessment, changes, technology transfer plan, batch production plan, batch production report and technology transfer report, etc.
4.Participate in process characterization project discussions, provide feedback on formulations and make constructive comments; responsible for the overall management of formulation process characterization, guide the assessment of formulation process parameters, develop critical research、parameter range research plans, and process control strategies; direct the execution of process characterization studies including draft of critical studies and parameter range study plans/reports, execution of studies, procurement and confirmation of related equipment and consumables, etc.
5.Responsible for implementing the planning and construction of MSAT labs and drafting laboratory rules and regulations and the procurement of instruments, equipment, materials and consumables related to DP MSAT lab.
6.Participate in the review of production process related documents; analyze production and R&D data, information, documents and reports; track process related deviations to ensure their authenticity, completeness and technical reasonableness.
7.Provide technical support for production related issues, conduct root cause analysis, provide solutions, develop prevention and improvement programs, and ensure product quality.
任职要求:
1.微生物、化学、药学等相关专业本科或以上学历。Bachelor degree or above in microbiology, chemistry, pharmacy or other related majors.
2.至少有六年制剂相关的工作经验；有两年团队管理经验；有国际知名药企工作经验的优先考虑。At least six years of DP related work experience; two years of team management experience; working experience in international well-known pharmaceutical companies is preferred.
3.熟悉、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。Familiar with and understand of GMP regulations and guidelines related to biological drug formulation; understand relevant requirements of China, ICH, EU and US FDA regulations for the formulation industry.
4.熟练使用各种办公软件；有良好的团队管理能力和沟通能力。Proficient in using various office software; good team management skills and communication skills.
5.具有良好的语言表达能力和书面写作能力；优先考虑能熟练使用中文及英文作为工作语言的候选人.Good verbal and written skills; preference will be given to candidates who are proficient in Chinese and English as working languages.
6.具有较强的内部组织、计划、管理及外部沟通、协调能力。Strong internal organization, planning, management and external communication and coordination skills.
7.具有在较短时间内做出决策的洞察力、观察力和判断力。Have the insight, observation and judgment to make decisions in a relatively short period of time.
8.具有丰富的管理经验，熟悉中、西方文化差异。Strong management experience and familiarity with Chinese and Western cultural differences.
9.具有较强的抗压能力，工作积极主动。Strong ability to resist stress and work proactively.