工作职责：

1、负责生物药生产的全面管理，下含2000L规模细胞培养车间、纯化车间和制剂车间各一间（负责3期临床样品的生产，生产申报及获批后的上市生产）；

2、建设完善车间岗位设置、人员配备及排班制度，解决大规模原液及制剂生产过程中的问题；

3、车间建成前期带领团队开展委托生产服务（CMO），承担后续生产线建设相关工作内容。

任职要求：

1、学历要求：硕士及以上学位；

2、专业要求：细胞生物学、生物工程、生物制药等相关专业。

3、工作经验：

（1）5年以上生物药GMP生产车间管理经验；

（2）负责过生物药生产申报工作，并获得上市许可,具有车间建设筹建经验.

（3）具有大型制药企业工作经验。

4、能力要求：

（1）熟悉全球生物药生产规范及生产申报法规要求；

（2）熟悉生物制品原液及制剂生产工艺流程，熟悉生物制品原液及制剂生产车间的管理和运行；

（3）具有高度的责任感和敬业精神。

5、语言要求：良好的中、英文沟通及写作能力。

Job Description:

• Responsible for the overall management of biologics production, including a 2000L cell culture facility, purification and preparation facilities (the production of Phase 3 clinical trial samples, manufacturing approvals and production of approved products);

• Establish and improve the personnel setup and scheduling, as well as solve problems in the production process of large-scale raw liquids and their preparation;

Lead the team to carry out the CMO function and undertake the related work for follow-up production line construction.

Requirements:

• Education: Master’s degree or above

• Academic background: Cell biology, bioengineering, biopharmaceutical, or other related fields.

• Work Experience

  • More than 5 years’ management experience at a biopharmaceutical GMP production facility

  • Responsible for BLA filings and obtaining approvals, with experience in designing a production facility.

  • Experience with large pharmaceutical companies

• Qualifications:

• Familiar with global biologics regulatory affairs (FDA/CFDA) ,

• Familiar with the production process of raw materials and preparations for biological products, as well as the management and operation of biologics production facilities.

• Highly accountable.

• Language: Good verbal and written skills in English and Chinese
  

上班地址：成都市温江区海峡两岸科技园新华大道2段666号