职位描述:

DS and DP process development and manufacturing

• Work with cross-functional teams for projection of DS and DP needs for preclinical and clinical programs

• Develop CMC strategies and oversee all CMC activities from preclinical development through commercialization

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

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

CMO management

• Selection, contract negotiation, management, and QC/audit of Contract Manufacturing Organizations (CMOs) for some pipelines

• Manage technology transfer activities between CMOs

Quality management

• Sets standards for compliance to meet regulatory requirements

• Implement stage appropriate analytical methods and protocols

• Ensure the systems and processes used internally or at CDMOs are in compliance with all relevant regulatory standards

Regulatory compliance

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

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

Responsible for hiring, training, supervising, evaluating, and managing employee performance in CMC function

任职条件:

• PhD or MS in biology, microbiology, biochemistry, biochemical engineering or relevant disciplines.

• At least 10 years of working experience in a pharmaceutical or biotechnology CMC/cGMP environment, including at least 3-year experience as CMC lead.

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

• Experience implementing technical, strategic and operational plans

• Excellent interpersonal and management skills

• Strong leadership capabilities with team management and talent development abilities.

• Fluent in English both oral and written.