MSAT Technical Lead - Drug Substance - Biologics

📋 Description

• Subject matter expert for DS Biologics manufacturing.
• Process owner of DS Biologics validation for Sobi products.
• Lead MSAT projects for process and cost improvements in lifecycle management.
• Lead internal/external manufacturing activities: changes, deviations, CAPAs.
• Review and approve SOPs and manufacturing instructions.
• Oversee product transfer, scale-up and external manufacturing.

🎯 Requirements

• University degree in Biology, Biotechnology, Pharmacy or related.
• 10+ years DS Biologics manufacturing for commercial use.
• Strong Upstream Manufacturing: cell banking and new working cell bank.
• Scale-down models and qualification experience.
• Regulatory guidelines familiarity and authorities' communication.
• Fluent in English; travel up to 30%.

🎁 Benefits

• Emphasis on work/life balance
• Collaborative and team-oriented environment
• Opportunities for professional growth
• Diversity and Inclusion
• Competitive compensation
• Making a positive impact for ultra-rare disease patients