Job description:

1.Oveee the whole technical trafer (TT) process, develop TT plan and protocol with internal team, oveeas plant and other stakeholde to make sure the success of TT, batch manufacturing and data analysis, and prepare TT report.

2.Cooperate with R&D team and prepare formulation process scale-up plan and protocol. Execute scale-up batch manufacturing, and communicate with R&D team to solve potential technical issues.

3.Prepare drug products manufacturing plan to match the clinical trial schedule according to the registration timeline, and plan commercial scale manufacturing plan after product launch

4. Establish production budgets; monitor the cost and effectiveness of production activities to optimize resources, prioritize spending, and achieve volume, quality, and manufacturing standards.

5.Collaborate with project team in plant cotruction U and process equipment confirmation

6.Collaborate with Quality team in quality system development, maintain GMP compliance liaising with relevant Chinese authorities.

7. Report and communicate with senior management team about working progress, problems and solutio, improvement thoughts, and other necessary information

8.Routine conference and communication with oveeas partner and lead the other side to push forward the project

Qualification

1.Master or Bachelor in Pharmaceutical related Sciences or Engineering

2.Bachelor with 8+ yea, Master with 6+ yea of experience in pharmaceutical industry, with hands-on experience of drug product TT and/or R&D manufacturing scale-up, optimization and verification, especially in sterile products

3.Solid undetanding of China GMP, knowledge of EU/FDA GMP is a plus

4.Excellent English and communication and coaching skills, working with oveeas partner or in a multinational company is preferred

5.Excellent project management and planning skills, result oriented

6.Hands-on management style, open to new technologies

7.Entrepreneurial, resilient and strong team spirit