M&S-Site Project Lead-Hangzhou
Core
Lead end-to-end project execution and technology transfer for new products/processes from R&D to the local manufacturing site in Hangzhou, ensuring compliance with GMP and quality systems.
Role type
Senior Site Project Lead (Pharmaceutical Manufacturing)
Builds
New product/process transfers, scaled-up manufacturing capabilities, and validated production lines for the Hangzhou facility.
Domain
Pharmaceutical manufacturing / Technology transfer / Project management
Required skills
Project management, Technology transfer, GMP compliance, Cross-functional team leadership, Financial acumen, Risk management, Stakeholder management, Process scale-up, Regulatory support, Digital tool proficiency
Preferred skills
Chemical/biochemical/pharmaceutical engineering background, Experience with FDA regulations, PPM experience
Technologies
Shine (project management tool), GMP systems, Digital project execution tools
Responsibilities
Develop project objectives and strategies with partners; Manage project planning including timelines, costs, scope, and risks; Lead technology transfer planning and risk management; Evaluate process and equipment capabilities against local site needs; Organize process scale-up, trial runs, and validation batches; Support regulatory affairs in dossier preparation; Ensure compliance with GMP and quality requirements; Coordinate cross-functional teams (R&D, Production, QA, Engineering, Supply Chain); Report progress to clients and global PPM teams.
Seniority
Senior, hands-on IC
