Senior Scientist II, Technology Transfer

Job Responsibilities

• Process Understanding & Internalization: Deeply participate in process development, scale-up, and validation for key projects at China sites. Master the core technical details and process characterization of upstream (cell culture) or downstream (purification) technologies.
• Transfer Documentation: Lead or co-author technology transfer packages, including critical documents such as process descriptions, validation reports, analytical methods, and change controls.
• Cross-functional Collaboration: Build strong collaborative relationships with Process Development, Quality, Engineering, and other departments. Internalize technical decision-making processes and problem-solving mechanisms.
• Transfer Simulation & Readiness: Under guidance, participate in technology transfer projects destined for overseas sites, undertaking partial technical interface responsibilities to build hands-on readiness.

Qualifications

• Education: Master's degree or higher in Bioengineering, Biochemistry, Pharmaceutical Engineering, or related fields; Ph.D. strongly preferred.
• Experience: 5+ years of experience in biopharmaceutical process development, scale-up, or technology transfer, including at least 2 years of relevant experience within a multinational pharmaceutical company.
• Track Record: Proven track record of fully leading at least one complete technology transfer project for a commercial or late-stage clinical product (from either the sending or receiving side perspective).
• Technical Expertise: Deep familiarity with Process Characterization (PC), Process Performance Qualification (PPQ), and the process validation lifecycle is highly preferred. Experience successfully supporting FDA/EMA inspections related to technology transfer or validation is strongly preferred.
• Process Specialization: Deep expertise in core processes and equipment for either upstream cell culture (bioreactors) or downstream purification (chromatography systems, filtration systems), depending on your specialization.
• Documentation Skills: Strong command of ICH Q8/Q9/Q10 guidelines and international GMP requirements for technology transfer. Ability to author high-quality, regulatory-ready technology transfer documentation.
• Data Analysis: Solid capabilities in data statistics and analysis (e.g., DoE, Minitab), enabling the use of scientific methods to solve complex process scale-up challenges.
• Bilingual Proficiency: Must possess native-level fluency in both Chinese and English. Ability to discuss complex technical details fluently in Chinese with teams in China, while writing high-quality technical reports and communicating effectively with overseas teams and regulatory agencies in English.
• Cultural Adaptability: Exceptional cross-cultural adaptability and resilience. Willingness to live and work in China for two years to genuinely integrate into Chinese teams and understand the local work culture.
• Leadership Style: A "coach-style" leader, skilled at both solving difficult technical problems and—more importantly—developing local technical talent and fostering team growth.