Director, CMC Management
- Lead CMC activities of protein based drug development and manufacturing. Provide leadership to all aspects of CMC Team activity.
- Ensure alignment of CMC activities with development and manufacturing plans. Chart the course, track progress against goals and outline key strategic events for project.
- Serve as the center of solution. Address any challenges and issues that arise. Make hard decisions.
- Engage with key stakeholders to ensure transparency on program status and alignment on program plans, goals, resource requirements and timelines.
- Build a solid communication with client senior management to ensure alignment
between WuXi Biologics and clients. Coordinate efforts and facilitates communication of team members to address client’s needs timely and effectively.
- Coach and evaluate performance of CMC team members. Recognize and reward members of good performance.
- Enhance CMC related business processes. Develop & update a strategy in response to changing business needs. Manage matrix of all aspects of CMC Team activity.
- Keep senior management and committee informed of project status. Monitor external scientific information and serve as a key link to external Key Opinion Leaders in area(s) of focus.
- Enhance current service offering and develop new clients. Assess business development opportunities which could impact program. Develop future perspectives.
- Advanced degree (PhD or MS) in Bio/Chemistry, Bio/Chemical Engineering, Life Science or related major with 5+ years of applicable work experience.
- Strategic view and leadership abilities as well as hands on problem solving skills. Experience in managing projects is required.
- Excitement about the vision and mission of WuXi Biologics.
- Experience in two or more functional areas in cell line development, cell culture, purification, analytical, formulation, MFG/MFG support, QC, QA, project management in the biologics industry.
- Experience with staff management and/or CMC team management.
- Ability to effectively work across all levels, functions, sites and companies. Excellent verbal and written communication skills in both English and Chinese.
- Experience in writing regulatory documents and submissions and ability to work on multiple CMC projects at a time
Primary Location: Shanghai/Wuxi, China
To apply please send your application to HR_Biologics@wuxiapptec.com.