Ping Feng

At Cynogen, I played a pivotal role in streamlining operations, particularly in product CMC development and quality assurance. My focus on IT support and people development led to significant improvements in operational efficiency and employee satisfaction. By participating in strategic financial planning, I contributed to the company's growth trajectory in the competitive biotech landscape.

Leading and managing biologics CMC development and daily business operation of Salubris Chengdu ： Reshaping organization and improving productivity; Setting up tech transfer process to improve effeciency and compliance; Developing IND and NDA filing strategy ; Building biologics development trajectory to ensure phase-appropriate activities ; Assessing ongoing projects for their marketability and manufacturability; identifying and nurturing next generation leaders; Participating or initiating product licensing -in and -out; Managing facility/equipment maintenance/improvement, warehouse and international shipment; Managing R&D QA to improve compliance and efficiency; Key members on several steering committee to support project evaluation, cross-company project management; Chairman for the technical review committee to support ongoing projects

Multi-tasked, energetic, strategic, critical and passionate Knowledge in depth on biological therapeutic development, life cycle management Experience in IND, IMPD, MAA and BLA filing with expertise in analytical, cell bank and stability area Management skill to direct a matrix team as CMC lead to let a project from phase I to Phase III Line management skill to oversee Analytical Sciences/Quality Control Department Establish and manage cell bank program Experience in drug production (Fill/Finish), oversee fill/finish function to supply drug for multiple clinical studies Build-up process and system to manage analytical method life cycle Establish reference standard, comparability, product characterization program Years of experience in managing Quality Control function Key member in PAI several audits People person with interests to support career development of direct reports

Albufusion protein, antibody therapeutics evaluation and expression; bioassay development

Immuno assay development to support pre-clinical studies of sveral drug candidates(Albufusions and antibodies) including PK assay, immunogenicity and neutralization assays