Principal Duties and Responsibilities

岗位职责

• Understandtechnical aspects of the job, best practices, andadhere tocGMP compliance.

  理解工作的技术原理，并遵守cGMP合规性。

• Provide daily operation support in QC laboratory.

  在QC实验室进行日常实验操作。

• Develop and qualify potency assay and impurity assays such as HCP, DNA, and Residual ProA methods to implement at GMP QC groups following ICH/USP/EP/CP guidelines.

  根据ICH/USP/EP/CP指南开发和验证生物效能实验和杂质分析实验方法例如HCP，残留DNA和残留ProA。

• Perform analysis of in-process and finished formulations according to SOPs.

  根据SOP对中间样品和制剂进行分析检测。

• Work to relevant cGMP standards testing in process checks and stability samples.

  依照相关cGMP标准进行中间样品和稳定性样品的检测。

• Develop and implement all necessary SOPs

  撰写和补充所有必须的SOP。

• Perform moderate data analysis and trending; document work according to GMP and notify management.

  进行适当的数据分析和趋势分析；根据GMP进行文件工作并通知管理人员。

• Any other tasks as assigned by the supervisor.

  主管分配的任何其他任务。

  
  

  Job Requirements

  工作要求

• Bachelor’s degree in a scientific discipline with 4+ years’ experience in quality control systems, or Master’s degree with 2+ years’ experience.

  本科及4年以上工作经验，或研究生及2年以上工作经验

• Strong background in standard and specialized methodologies for biologics products.

  有生物产品方法开发或检测的相关背景。

• Understanding of FDA and ICH guidelines as well as GLP/GMP principles associated with analytical development.

  了解FDA和ICH指南以及与分析方法开发相关的GLP / GMP原则。

• Understanding of the basic statistics required in data analysis.

  了解数据分析所需的基本统计学。

• Experience developing bioassays and biophysical potency assays.

  有生物活性检测方法和其他生物学实验方法开发的经验。

• Experience developing process impurity assays such as HCP, Residual DNA, and Residual ProA methods is preferred

  具有杂质分析方法开发（如HCP，残留DNA和残留ProA方法）的经验会优先考虑。

• Excellent oral and written communication skills in English and Mandarin (Read, Write, Verbal) demonstrated by communicating with other functions and management regarding resolving investigations and theory, ability to write technical documents and statistical analysis of QC data.

  有良好的英语和普通话的口语或者书面沟通能力，能与其他职能部门和管理层就调查问题，解决问题，文件撰写以及QC数据的统计分析进行沟通。

• Highly motivated, flexible, and multi-tasks

  高度积极性，灵活性和多任务解决能力。