biologics manufacturing, ed / vp.

【Key Responsibilities】
1.End-to-End Production Management: Direct site-wide commercial manufacturing operations covering full-process Drug Substance (DS) and Drug Product (DP) sterile fill-finish.
2.Large-Scale Biomanufacturing: Drive operational excellence across 5,000L+ stainless steel bioreactor production lines, upstream cell culture, downstream purification, and advanced conjugation processes.
3.Global Regulatory Readiness: Lead manufacturing operations through US FDA Pre-Approval Inspections (PAI), EMA audits, and NMPA GMP compliance inspections.
4.Operational Excellence & Cost Control: Implement lean manufacturing practices, enhance process yield, manage manufacturing budgets, and optimize resource allocation.
5.Cross-Functional Leadership: Partner closely with QA/QC, MSAT/CMC, Engineering, EHS, and Supply Chain to ensure seamless tech transfer and commercial supply.
6.Team Leadership: Build and mentor high-performing manufacturing teams, fostering a strong culture of compliance, safety, and operational efficiency.

【Qualifications & Requirements】
1.Education: B.S. or higher in Biochemical Engineering, Biotechnology, Pharmacy, or related fields (Master's / Ph.D. preferred).
2.Industry Experience: 10+ years of commercial biomanufacturing experience, including 5+ years in senior executive leadership at a multinational pharmaceutical company (MNC) or top-tier Biopharma.
3.Technical Expertise: Deep hands-on management of 5,000L+ stainless steel bioreactors and full-process DS + DP (sterile fill-finish) operations for complex biologics.
4.Regulatory Track Record: Proven success in leading biomanufacturing facilities through US FDA, EMA, or NMPA site inspections and commercial BLA approvals.
5.Language Skills: Professional proficiency in both English and Mandarin (capable of leading technical and regulatory discussions with global audit inspectors).