Responsibilities岗位职责:

1.Responsible for building and leading the ADC (Antibody-Drug Conjugate) DP tech transfer & validation team. 负责ADC 制剂技术转移和验证团队组建。

2.Interface with the headquarters and global teams to optimize the ADC DP technology transfer process.和总部以及全球同事合作建立和优化制剂技术转移流程。

3.Responsible for new products introduction (NPI) analysis and process gap analysis. 负责新产品引入评估和差异分析。

4.Responsible for conducting process risk assessment, CPP identification, and conducting necessary supplemental PD and characterization studies. 负责对引入工艺进行风险评估，识别关键工艺参数，并开展必要的补充工艺研究和表征实验。

5.Responsible for drafting technology transfer relevant documents and trial batches protocol. 负责技术转移相关文件的起草，负责试验批次方案的制定。

6.Lead the PPQ readiness preparation and drafting PPQ related documents. 领导PPQ的准备过程，负责PPQ相关文件的起草。

7.Support the investigation of process related deviations and root cause analysis. 支持相关工艺偏差的调查和根本原因分析。

8.Responsible for regulatory filing dossiers preparation. 负责相关申报资料的撰写。

9.Lead the post-commercialization continuous process validation. 领导产品上市后的持续工艺验证。

10.Responsible for conducting validation works including facility/equipment PQ, aseptic process validation, cleaning validation, etc.. 领导车间的相关验证工作，包括但不限于产线PQ，无菌工艺验证，清洁验证等。

11.Responsible for production process risk assessment and risk management, such as contamination and cross contamination control. 负责车间的相关风险评估和风险管理工作。

Qualification任职资历:

Over 10 years of experience with biological drug products in the pharmaceutical industry, at least 5 years of biologics DP technology transfer experience; experience in ADC (antibody–drug conjugate) drug product production or tech transfer is preferred

10年以上制药行业无菌制剂相关工作经验，其中至少5年以上生物制剂技术转移经验；具有ADC药物制剂相关经验者优先

Expert in aseptic lyophilized drug product manufacturing and GMP compliance; expert in process validation and end-to-end technology transfer for biologics; strong problem-solving and process optimization experience; exceptional team leadership and cross-functional collaboration

精通无菌冻干制剂的生产工艺，熟悉GMP法规要求；

精通工艺验证；精通生物制剂技术转移流程管理；