TJ007 Manufacturing Director

TITLE:            Manufacturing Director

LOCATION:  Tianjin, China

REQ#:                         TJ007

Company Overview: Jecho Biopharmaceuticals Co., Ltd. is a biopharmaceutical company manufacturing innovative therapeutic biologics to address a broad range of infectious diseases as well as treatment of cancer. The company headquarter is located in Tianjin China.

Responsibilities:

  • Work with the technology transfer department to finished the process & engineering amplification and process optimization.
  • To be responsible for pilot scale production and clinical production.
  • To be responsible for implementation of manufacturing with coordination of all resources, QC for in process testing, facility maintenance, engineering, and administrative support.
  • Solve comprehensive manufacturing problems including prioritizing manufacturing activities, schedules, and resources in aligning with company’s priority.
  • To be responsible for the team building, budgeting, project timeline management, personnel training and performance evaluation of the manufacturing team.
  • Collaborate with quality departments on facility qualification including utility calibration and validation, process validation, personnel GMP training, environment monitoring, QC testing, and final product releasing.
  • Assist regulatory affair activities for DMF, IND, and NDA/BLA submission.
  • Other assignments from the direct manager.

Minimum Requirements:

  • Graduate degree in biochemical engineering, biological sciences or related field. Minimum 10 years biopharmaceutical experiences with ~5 years managerial responsibilities at a level of senior manager of a department. Ph.D. is a plus.
  • Extensive experiences with microbial fermentation, mammalian cell culture, protein purification, formulation, viral vector production, and PAT in in-process testing.
  • Extensive large-scale manufacturing experiences with GMP operation background is a plus.
  • Extensive management experiences. Strong leadership, organization ability.
  • The candidate must be excellent with bilingual (English and Chinese) communication, professional writing and interpersonal skills.