职位描述:

1.Develop CMC PD strategies and oversee all Process Development activities from preclinical development through commercialization

2. Responsible for CMC process development of biological drugs, responsible for technology transfer, risk assessment.

3. Drive process improvements and efficiencies across different stages of development and clinical/commercial manufacture

4. Review/approve master batch records and protocols for DS/DP manufacturing runs, analytical release testing, stability studies, and investigations

5. Manage technology transfer activities between CMOs

6. Support IND, BLA filling by writing/reviewing regulatory materials or process changes (PD chapters) to ensure regulatory approval

7. Review or edit cGMP batch records, CMC regulatory and Quality documents

8. Responsible for hiring, training, supervising, evaluating, and managing employee performance in PD function

任职条件:

1. Science PhD

2. 8-10 years of working experience in a pharmaceutical or biotechnology CMC/cGMP environment, including at least 5-year experience as process development lead.

3. Experience with projects in clinical development, cGMP manufacturing and IND, CTA, and NDA filings.

4. Experience implementing technical, strategic, and operational plans

5. Excellent interpersonal and management skills

6. Strong leadership capabilities with team management and talent development abilities. 7. Fluent in English both oral and written