- Lead and manage the PD organization, including PDU (Cell Culture), PDD (Purification), Formulation Development, and Analytical Method Development, to achieve the strategic goals of the company.
- Support the development of various biosimilar, bio-better, and fast-follower products for China and global regulatory filings and commercialization.
- Recruit, train, and develop talents at all levels in the PD organization.
- Coordinate with the manufacturing organization for tech transfer of developed manufacturing process to support late-phase and commercial manufacturing.
- Provide technical guidance and support to the manufacturing group.
- Establish solid documentation systems within the PD organization, to record and document all PD studies to support regulatory filings and inspections, as well as business development and financing projects.
- Adopt and/or develop new PD technologies for improvement of quality, speed, and/or cost effectiveness.