Director, Downstream Process Development - Wuxi

People management, training, and development to ensure his/her team perform well in a fast-paced environment. Execute and/or oversee downstream process development, scale-up, technology transfer, and process characterization. Design the downstream processes that are efficient, robust and scalable for clinical and commercial manufacturing. Guide risk assessment and mitigation strategy development. Acting as interface with other internal teams and clients effectively Support IND/BLA filing including preparation of dossiers and assisting communications with agencies and accommodating audits. Advance process technology to ensure business competitive edge by identifying innovation opportunity, leading laboratory development and validation of technologies, implementing technologies to business platforms. Assist the function head to coordinate the works between the downstream development group and other functional groups to meet department goals. Basic

MS with 10+ years, or PhD with 5+ years in both early-stage and late-stage downstream process development experience. At least 4 years of people management experience and having strong management and leadership skills. Skilled in statistical analyses and methods, e.g. Design-of-Experiments. Have a good deep understanding of the limitations of manufacturing when designing and scaling up purification processes. Familiar with budgeting processes for projects, personnel, equipment and lab space. Experienced in IND/BLA filing to CFDA, FDA, and EMA. Experience in technology platform development and implementation will be considered as an advantage. Good commends in spoken and written English. Skilled in working with cross-functional teams and clients.