Director, Downstream Process Development - Wuxi

Responsibilities:

• 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 Qualifications:

• 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.