TJ003 VP Manufacturing

TITLE:            Vice President, Manufacturing

LOCATION:  Tianjin, China

REQ#:                          TJ003

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:

  • Take leadership on manufacturing
  • To be responsible for organizing GMP manufacturing operation from clinical phase III and commercial manufacturing for market products. 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. 
  • Organize a team of up to 300-500 technical and manufacturing staffs in several departments with responsibility of budgeting, deliverable timeline, senior level personnel training and evaluation. 
  • Provide updated working timetable to the executive committee and present report to the CEO.
  • Coordinate activities among departments on quality operations, business operations, technical operations, regulatory affair, clinical management, and engineering department.
  • 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.
  • Organize company manufacturing board meetings, coordinate all manufacturing activities with related departments.
  • Assist regulatory affair activities for DMF, IND, and NDA/BLA submission.

Minimum Requirements:

  • Graduate degree in biochemical engineering, biological sciences or related field. Minimum 15 years post-graduate degree biopharmaceutical experiences with ~8 years managerial responsibilities at a level of director 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.
  • Extensive management experiences. Strong leadership, organization ability, wide range of GMP knowledge on FDA or EMA or CFDA regulation.  
  • Demonstrated track record in biopharmaceutical manufacturing till phase III and commercial production for market products.
  • Works within approved budget. Develops and implements cost saving measures. Contributes to potential profits and revenue. Conserves organizational resources.
  • The candidate must be excellent with bilingual (English and Chinese) communication, professional writing and interpersonal skills.