Associate Director / Director, CMC Product Development

Added
1 day ago
Type
Full time
Salary
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Related skills

regulatory adcs cmc cell therapy drug development

📋 Description

  • Manages multiple clinical development programs of high complexity using matrix management.
  • Leads CMC teams and PPDS T teams with cross-functional partners for external collaborations.
  • Co-chairs PPDST for Asset Strategy Teams and crafts CMC strategy aligned to asset strategy.
  • Acts as CMC spokesperson; ensures information flow among AST, line functions, and stakeholders.
  • Supports global filings and regulatory communications; informs management of plans and risks.
  • Scope from late-discovery to tech transfer to commercial manufacturing sites.
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