Hong Kong, Hong Kong SAR
1.Process Development: Participate in 5 project's upstream cell culture process development, experimental design, optimize the process parameters. 2.Technology Transfer: responsible for technology transfer process, risk management, familiar with upstream scale-up production operations, and promote the smooth progress of the project. 3. GMP Operation & Quality management (DS): master the key operation of cell culture in GMP Drug Substance (DS) production. Familiar with GMP quality management system, participate in deviation investigation. 4. GMP Project Management Function Leader (DP): Responsible for material management prior to Drug Product (DP) manufacturing process, delivering GMP documents such as MBR, BOM, facilitate cross-department communication, manage customer PIP and visit reception, lead the microbe OOL (out-of-limit) deviation investigation. 5. Audit Support: Write 5+ audit standard instruments to improve the company's audit pass rate. 6. Support US site: Master Batch Record Evaluation, Contamination Control Strategy drafting, Change Control support, Expansion of standalone business, promoting the full process evaluation of license-in business, including cell line development, process development, GMP production feasibility, and regulatory affairs. 6. Achievements: Awarded First Prize in the Elite Program Management Trainee Defense, received Thank you letter from customer.