锦鲤求职岗位描述
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 clients 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.