Director, Manufacturing Sciences and Technology (MSAT)

Added
8 days ago
Type
Full time
Salary
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Related skills

gmp process engineering process validation technology transfer regulatory cmc

πŸ“‹ Description

  • Lead and develop a high performing MSAT team establishing robust technical transfer, process
  • Act as a technical subject matter expert when needed while leading and coaching team members across
  • Establish the global MSAT strategy and provide technical leadership across late-stage development
  • Provide technical leadership for CDMO evaluation, onboarding, technology transfer, validation
  • Partner with External Manufacturing and Quality leadership to resolve technical, process, and
  • Proactively identify critical path activities, technical risks, resource needs, and budget

🎯 Requirements

  • BS degree with 10+ years or MS degree with 8+ years in Chemical Engineering, Biological Sciences
  • Experience with drug substance and drug product manufacturing technologies relevant to peptides
  • Deep expertise in Quality by Design (QbD), with advanced knowledge of cGMP expectations and
  • Proven ability to operate independently, influence without direct authority, and make sound
  • Excellent leadership, communication, collaboration, technical writing, and executive-level
  • Strategic thinker with discipline and execution focus.
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