Responsibilities:
Responsible for GMP routine testing, method evaluation/transfer/qualification/validation experiments, method optimization/trouble shooting, laboratory investigation, investigational experiments and related record documentation in QC biochemistry group.
1.Promptly and properly document tests and results per Good Documentation Practice (GDP) requirement.
2.Perform GMP routine testing and method setup experiments of Antibody-Drug Conjugate (ADC) samples according to relevant Standard Operation Procedure (SOP), Analytical Method Procedure (AMP), protocols, test methods and cGMP requirements.
3.Write and revise AMP, method transfer/qualification/validation protocol and report.
4.Write SOP and other technical documents
5.Perform laboratory investigation following relevant SOP.
6.Perform method optimization and troubleshooting when necessary and lead technical discussion.
7.Review test records including lab notebook, worksheet, electronic data and audit trail.
8.Perform deviation investigation, change control, and CAPA following relevant SOP.
9.Work as QC Function Leader to coordinate project related activities in QC.

Requirements:
1.Education background in Chemistry, Biochemistry, Microbiology, Molecular Biology, Biological Engineering, or others related field.
2.One to three year experience in (bio)pharmaceutical industry.
3.Knowledge in some the following fields: Biochemistry related skills like ELISA binding, cell based potency assay, cell culture.
4.Knowledge in FDA/EMA/CFDA cGMP regulations, Pharmacopoeias, and ICH guidelines
5.Good communication skills in English and Chinese.
6.Critical thinking, scientific reasoning and problem solving skills
7.Good computer operation skill, intermediate level in Microsoft Word, Excel, PowerPoint etc.