职位描述

Top Job Responsibilities: 1. Provide global technical leadership to integrate and streamline technology transfer activities and control strategies within company global MFG network and across projects. 2. Lead the technology transfer of late-stage projects, including the identification and assessment of risks in technology, process, quality, and regulations, and develop good regulatory filing strategies. 3. Lead the activities of facility fit, safety risk assessment for new product introduction and site change of late-stage projects. 4. Guide the process validation, equipment verification, and environmental monitoring. 5. Lead the development of manufacturing strategy, as well as the implementation, optimization and completion of production plan and product quality control for late-stage and commercial projects. 6. Lead the continuous monitoring of commercial production and the management of the product lifecycle. Identify areas for improvement and implement measures to improve efficiency and reduce production costs. 7. Guide the deviation investigation and change control for late-stage and commercial projects. 8. Provide support for ******s and regulatory audits and lead the team to respond to audit related questions and implement corrective actions to address audit findings. 9. Promote good customer relationship and explore customer business needs and support contract proposal and discussion along with BD team for late-stage projects. Opportunities: 1. Join a highly dynamic CRDMO company with locations in China, APAC, Euro and USA 2. Working with cross-function teams with deep scientific and GMP manufacturing expertise 3. Offered opportunities to utilize and develop your CMC experience in the pharmaceutical industry from process develop, tech transfer, and commercialization 4. Develop strong leadership and communication skills to facilitate contributions from different functions Required Qualifications: 1. Advanced degree (PhD or MS) in Bio/Chemistry, Bio/Chemical Engineering, Biotechnology, Life Science or related major with 8+ years of applicable work experience. 2. Good knowledge and experience in CMC strategy, risk and resource management, tech transfer, process qualification, biomanufacturing, deviation investigation, regulatory filing and life cycle management. 3. Excellent project management and communication capability. 4. Willingness to travel up to 10% 5. Be willing and able to work in China and other countries

其他要求

招聘人数: 1
职能类别: 工艺工程师

公司介绍

上海药明生物技术有限公司是上海药明康德新药开发有限公司的全资子公司,由原来的生物制药和生物工艺部,生物新药发现部独立出来成立了一家专门做生物制药的公司,这两个部门于2011年成立,于2015-5-1号独立出来组建新公司,是全球领先的制药、生物技术以及医疗器械研发开放式能力和技术平台公司,在上海和无锡均有运营实体。作为一家以研究为首任,以客户为中心的公司,药明生物向全球制药公司、生物技术公司以及医疗器械公司提供一系列全方位的实验室研发、研究生产服务,服务范围贯穿从药物发现到推向市场的全过程。药明生物的服务旨在通过高性价比、高效率的研发服务帮助全球客户缩短药物及医疗器械研发周期、降低研发成本。 公司官网:http://www.wuxiapptec.com.cn 地址:中国上海外高桥保税区富特中路288号 查看地图发送到手机 邮政编码:200131

企业信息

  • 名称:上海药明生物技术有限公司
  • 行业:制药.生物
  • 性质: 中外合营(合资/合作)
  • 规模: 500-999人

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