(Associate) Director, Drug Product Operations

📋 Description

• Lead DP strategy and process development for early-stage programs
• Define FIH & Phase 2 strategy: formulation interface, fill/finish, container selection
• Own DP process development and tech transfer to clinical manufacturing
• Identify and resolve DP bottlenecks to protect timelines
• Drive CDMO selection and vendor oversight for Phase 1/2 manufacturing
• Coordinate regulatory submissions for DP CMC sections

🎯 Requirements

• 10+ years in biopharma development with DS/DP ownership
• Experience with DS/DP unit operations and analytical sciences
• Proven CDMO/vendor leadership for clinical-scale manufacturing
• Regulatory acumen in authoring CMC sections for INDs
• Education: BS/MS/PhD in Chemical Engineering or related

🎁 Benefits

• Salary $193,000 - $246,000 (US-based)
• Annual bonus plan and Equity Incentive Plan
• 401(k) with employer matching
• Comprehensive medical/dental/vision and well-being support
• Open vacation policy and parental leave
• Home office setup stipend and stipends for mobile/internet