Responsibilities:

• Support daily activities of a QC Microbiology lab which performs various microbiological tests of in-process, drug substance, drug product, and environmental monitoring samples. Perform growth promotion and microbial identification if necessary.

• Guide microbial method validation/verification and ensure the test methods in compliance with regulatory and company requirements.

• Lead problem solving and troubleshooting; identify and resolve technical testing issues

• Write and review study protocols, reports, SOPs, and filing documents. Review EM trending reports and EM excursion investigation reports.

• Work collaboratively across organization and sites for microbiological related verification/validation/investigation to meet organizational goals.

• Present project results both internally and externally as needed.

• Initiate and introduce new scientific knowledge and keep an updated regulatory knowledge.
  

Requirements:

• Ph.D. or MS in Microbiology.

• Ph.D. with 1 + years, M.S. with 3 + years of experience in microbiology related industry experiences is desirable.

• Knowledge of microbial identification, environmental monitoring, and microbiological testing is desired. Experience in support biopharmaceutical manufacturing is highly desirable.

• Ability to think critically and demonstrate troubleshooting and problem solving skills.

• Excellent interpersonal skill and verbal and written communication skills in both English and Chinese .

• Comfortable in a fast-paced company environment and able to adjust workload based upon changing priorities.

上班地址：无锡滨湖区马山梅梁路108号

药明生物（股票代码：2269.HK）作为一家香港上市公司，是全球领先的开放式、一体化生物制药能力和技术赋能平台。公司为全球生物制药公司和生物技术公司提供全方位的端到端研发服务，帮助任何人、任何公司发现、开发及生产生物药，实现从概念到商业化生产的全过程，加速全球生物药研发进程，降低研发成本，造福病患。截至2018年6月30日，在药明生物平台上研发的综合项目达187个，包括98个处于临床前研究阶段，78个在临床早期（I期，II期）阶段，10个在后期临床（III期）以及1个在商业化生产阶段。预计到2021年，公司在中国、爱尔兰、新加坡、美国规划的生物制药生产基地合计产能约22万升，这将有力确保公司通过健全强大的全球供应链网络为客户提供符合全球质量标准的生物药。如需更多信息，请访问：www.wuxibiologics.com.cn。
药明生物员工总数超过4000人，其中300多位是具有海外高等学位和工作经验的海归科学家，拥有欧美市场抗体开发、生产、质量控制、临床前研究和国际注册经验，高级管理层团队成员均工作在生物制药行业一线，并在各自专业领域平均拥有超过20年行业经验，打造了世界一流的生物药发现、开发及生产团队。