The Director/Associate Director, Upstream Process Development, will lead and actively engage in process development within upstream PD team to develop, optimize and scale up mammalian cell culture processes for biologics production and support subsequent GMP manufacturing. The candidate will provide significant scientific and technical contributions within the team. As a core member of management team, the candidate will be responsible for the strategic planning and growth of upstream functions.

Responsibilities
• Lead upstream team to develop, optimize and scale up mammalian upstream processes and primary recovery for biologics production
• Lead media development activities to optimize the current media platform
• Oversee and define project scope and ensure successful delivery regarding technical quality, timeline and budget
• Direct upstream innovation projects, new technology evaluation / implementation, as well as conference presentation and journal publication
• Support IND/BLA CMC upstream process document preparation
• Work with MST on process scale-up, scale-down and late-phase process characterization/validation using QbD approach
• Work with MST to manage process/technology transfer (externally from client or internally to Manufacturing), and provide manufacturing support and troubleshooting
• Serve as the technical project lead for the development of robust high performing upstream processes with emphasis on transferability to cGMP manufacturing.
• Contribute to department and corporate strategic planning and objectives setting
• Mentor team members and manage department budget
• Provide technical support to business and sales team and represent upstream development functions in client meeting

• PhD degree in Biochemical Engineering or related fields with 8+ years of upstream process development, media development, tech transfer and/or manufacturing experience
• Strong background in mammalian cell culture (CHO) process development, optimization and scale-up/down
• Strong background in cell culture media development
• Strong background in primary recovery (centrifugation, depth filtration) optimization and scale-up/down
• Extensive experience in biologics (mAbs, recombinant proteins, factors) late-phase process characterization, tech transfer, manufacturing support and troubleshooting
• Strong experience in PAT technologies, GMP / ICH guidelines, CMC and IND/ BLAs document preparation
• Excellent cross-functional communication, written and presentation skills
• Excellent team building, leadership and management skills and proven ability to work with a high level of integrity, accuracy, and attention to detail