💼 About This Role

You'll lead upstream MSAT and process development for biologics, supporting externally partnered GMP production. You'll drive design, scale-up, and technology transfer of drug substance processes globally.

🎯 What You'll Do

• Lead upstream MSAT and process development team for biologics
• Design and oversee upstream process development from early to commercial stage
• Manage CDMO relationships for upstream process development
• Author regulatory submission sections for CMC

📋 Requirements

• Ph.D. or M.S. in Chemical Engineering, Biochemistry, or related field
• 8+ years biopharmaceutical experience in MSAT and process development
• 4 years in a leadership role
• Experience with technology transfer and external CDMOs

✨ Nice to Have

• Experience in a lean, entrepreneurial biotech environment
• Familiarity with integrated CMC program leadership