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Insitro

(Associate) Director, Drug Product Operations

Hybrid
Engineering
Added
8 days ago
Location
Type
Full time
Salary
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distributed systems chromatography cdmo dp ufdf
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📋 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
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