TJ007 Manufacturing Director
- Details
- Category: Current Openings in Jecho Bio, Tianjin, China
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.