A proven track record of technical operation executive in biotech, pharmaceutical and specialty chemical industries: * More than ten years experience of operations management, budget control, P&L responsibility, and project strategic planning. * More than twenty years of product development and manufacturing experience from early to late development stage and commercialization in therapeutic areas: cardiovascular, oncology, vaccines (including immunotherapy for cancer vaccines), immunology and dermatology.* Hands-on experience of project planning and management. Excellent team work attitude and leadership to nurture cross functional development teams, Pre-clinical, Clinical Development & Operations, QA&RA, and CMC.* Demonstrated leadership in designing technical organizations and recruiting, motivating and developing high-performing diversified culture-background teams. * A strong background and knowledge in process, assay & formulation development, technology transfer, manufacturing, and supply chain management including contract negotiation and managing outsourcing activities at CMOs (contract manufacturing organizations) and CROs (contract research organizations).* An established track record of effective project oversight and project execution leading to successful IND and NDA filings. Solid knowledge and understanding of cGMP and regulatory guidelines and processes (US FDA, EMEA, and Japan PMDA).* Demonstrated leadership and communication skills working in a matrix global team environment.* Familiar with virtual business operation mode, and international business environment (US, Japan, Europe and China).* Innovative on new technology development with three world-wide issued patents on new technologies and processes.Specialties: * Product development and project management* Manufacturing process development and operations* Technology evaluations for in-licensing and out-licensing
Listed skills include Biotechnology, Technology Transfer, Biopharmaceuticals, Commercialization, and 20 others.