Description

Formulate annual cdmo plan according to the clinical promotion plan; Follow up CDMO enterprises to ensure that production is carried out as planned; Be responsible for the management of deviation, change and CAPA, organize the investigation, track and review analysis; Collect and analyze the statistical production data and put forward the optimization plan; Master relevant information such as process flow, production cycle, consumption of raw and auxiliary materials and production capacity, and provide data support and suggestions for relevant decisions; Regularly check whether the implementation of each production site is consistent with the provisions of the production and operation documents. Participate in the drafting of quality review report and self-inspection report, and participate in the implementation of quality review and self-inspection management; Review the environmental monitoring and process water monitoring plan; Complete other related work.

Requirements

More than 2 years of production and operation management experience in large pharmaceutical enterprises, especially in the development and quality control of production processes such as AAV, mRNA vaccine and small nucleic acid drugs; Master degree or above in biology related major, with AAV related research background is preferred; Proficient use of HPLC, LC-MS, capillary electrophoresis, qPCR, DDPCR and other tools for quality analysis and characterization of biological products is preferred; Familiar with biomedical analysis and detection, and experience in analytical technology development and verification is preferred; Be familiar with GMP related regulations and certification procedures, have a certain understanding of relevant regulations and principles of gene drug development, and have a good sense of compliance; Be able to read English literature and write plans and reports.

CMC Engineer

Description

Requirements

SineuGene