Principal Duties and Responsibilities

• Understand technical aspects of the job, best practices, and adhere to cGMP compliance.

• Provide daily operation support in QC laboratory.

• 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.

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

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

• Develop and implement all necessary SOPs

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

• Any other tasks as assigned by the supervisor.

  
  

  Job Requirements

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

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

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

• Understanding of the basic statistics required in data analysis.

• Experience developing bioassays and biophysical potency assays.

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

• 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.

• Highly motivated, flexible, and multi-tasks.

上班地址：武汉东湖开发区高新二路388号