Participate the recruitment of process development and analytical development team, retain and develop talents, and provide leadership for a high performing team to meet overall business objectives.Lead the set-up of Process Development lab. Drive the development of robust, cost-effective recombinant plasmid DNA and other novel viral vector’s manufacturing processes, for client’s cell and gene therapy applications. Lead the tech-transfer and process scale-up.Apply Quality by Design principles to develop a deep understanding of the plasmid DNA platform manufacturing process and to define robust, integrated control strategies.Establish the procedures of direct tech transfers, and the capability of process lock-in pilot runs.Develop and maintain detailed and comprehensive project timelines and budgets.Lead the preparation of CMC sections for regulatory submissions (IND, Annual Reports, and BLA), invention disclosures, progress reports, and publications.Present updates to project or upper management teams on process development and manufacturing support activities.Maintain a high level of knowledge in gene and cell therapy, sensitive in the field of plasmid DNA and other novel products development and manufacturing.Perform other duties as assigned based on business needs.Up to 15% traveling to support CDMO projects or business development activities.