Bio-pharmaceutical Process Director


Job Description

1. Responsible for process development in bio-pharmaceutical projects and CMC strategy design, and controlling project quality and progress;

2. Responsible for establishing process development technology platform and process development;

3. Developing bio-pharmaceutical process and managing project implementation, supervising and controlling CMC development process, and ensuring project quality and progress;

4. Reviewing and approving CRO's process technology plans;

5. Directing the preparation of IND application documents related to process development and production;

6. Supporting project management department to complete relevant plans and tasks;

7. Supporting R&D department to optimize the initiation and evaluation of bio-pharmaceutical development projects.

    Job Requirements

1. Holding a master's degree in Molecular Biology, Cell Biology, Bioengineering, Biochemistry and other related majors; those who worked in large pharmaceutical enterprises, or foreign-funded/overseas enterprises are preferred;

2. Proficient in cell culture, protein purification and other related fields, and have knowledge with bio-preparation technology and sterile preparations;

3. Have been engaged in antibody process development for more than six (6) years (working on over two (2) relevant projects), and team management for over five (5) years. Those who worked in the same position are preferred;

4. Proficient in using tools for DOE, and familiar with QbD process development concepts;

5. Familiar with ICH's regulations on drug development and GMP;

6. Being ambitious, responsible and a proven good team player.

7. Proficient in English.

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