职位描述
职位描述: 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.- Extensive management experiences. Strong leadership, organization ability, wide range of GMP knowledge on FDA or EMA or CFDA regulation.- The candidate must be excellent with bilingual (English and Chinese) communication, professional writing and interpersonal skills. 职能类别: 生物工程/生物制药