武汉招聘

职位描述：
? Oversee the activities related to late phase process development, process characterization, and process validation, as well as BLA readiness.
? Write, revise and review protocols and reports related to process characterization, and process validation in compliance with all applicable regulations, including but not limited to process validation, column/membrane/system cleaning validation, resin/membrane lifetime validation, etc.
? Write, revise and review other related documentation as necessary to support late phase product development and BLA application.
? Assist on the activities related to process and method tech transfer, process scale-up and cGMP manufacturing.
? Take on other tasks as needed by MSAT or the company.
? Build the future of the organization through developing employee’s knowledge, understanding, and skills to improve performance and expand abilities
? Ensure collaboration and commitment between MSAT and other departments in order to meet internal and external expectations

鼎康生物是一家领先的CDMO公司，可提供一站式的CMC解决方案，支持从早期药物开发到后期临床研究和商业化cGMP生产。鼎康引进了全球***模块化生物制药工厂Kubio；为客户开发的多个产品已经在全球20多个国家进行临床试验。在不久的将来，鼎康生物总产能将超过140,000L。我们承诺通过技术和生产创新，使全球患者都能负担得起具有国际标准的生物药物，提高治疗水平以改善人类健康。