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Director or Senior Director, CMC Program Management

Kymera Therapeutics

Kymera Therapeutics seeks a Director or Senior Director to manage chemistry, manufacturing, and controls programs for mid-to-late-stage oral small molecule degrader candidates. The role encompasses timeline planning, cross-functional coordination, regulatory submission support, and CMC strategy for programs advancing through clinical and commercial stages.

Responsibilities

  • Drive end-to-end CMC program management including timeline development, critical path identification, and risk assessment
  • Build and maintain integrated plans spanning drug substance, drug product, analytical, quality, regulatory, and supply chain
  • Support Phase 3, registration, validation, and commercial readiness activities for oral solid dosage forms
  • Lead CMC team meetings and communicate status, risks, and decisions to stakeholders and external partners
  • Coordinate CMC documentation preparation and timely delivery for global regulatory filings

Requirements

  • Advanced degree in pharmaceutics, pharmaceutical sciences, chemistry, or chemical engineering preferred
  • 10+ years of CMC program management experience for oral small molecule drugs
  • Experience advancing programs through Phase 3, NDA/MAA submission, and process validation
  • Broad technical knowledge of drug substance, drug product, and analytical development
  • Prior experience with CDMOs, CROs, technology transfer, and GMP manufacturing
  • Demonstrated ability to manage timelines, assess risk, and coordinate across functions
Vacancy posted 8 days ago
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