Associate Director, Protein and ADC Drug Substance

Role Overview

• Provide project overarching drug substance support mainly protein purification and ADC bioconjugation
• Serve as a local interface for all clinical CMC project teams with Chinese collaboration partners, CDMOs, and vendors
• Engage directly with local collaboration partners, CDMOs, vendors to support drug substance development and GMP manufacturing for protein and ADC projects
• Support operational & troubleshooting activities on-site
• Support technical transfers to in-China and ex-China sites
• Conduct internal audits, and Health Authority inspections
• Collaborate with Product Supply and Quality counterparts to enable efficient technical project handover to commercial operations

Requirements

• Master’s degree in chemistry, Biopharmaceuticals, Biochemistry, Biology, or a comparable field
• At least 5 years of relevant professional experience in an international and highly regulated environment
• Proven experience in mAb and ADC Drug Substance process technologies
• Specific operational experience in mAb DSP or ADC bioconjugation
• Sound experience in CMC development of early
• and late-stage projects
• Sound GMP knowledge and experience with regulatory filings for biologicals (IND/IMPD, BLA/MAA)
• Excellent project management skills
• Capable of working in cross-functional CMC teams and with external stakeholders
• Excellent communication and negotiation skills

Benefits

• Competitive remuneration packages
• Wellbeing support for team members