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Associate Director, Analytical Development

Kymera Therapeutics · Watertown, MA

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Role summary

Kymera Therapeutics seeks an Associate Director of Analytical Development to lead CMC analytical activities supporting clinical and commercial development of small-molecule protein degraders. The role involves method development, validation, stability monitoring, and regulatory submission support in partnership with contract manufacturers.

What they're looking for

  • PhD in Analytical Chemistry or related life sciences field preferred
  • 10+ years CMC analytical development experience with small molecules and oral solids
  • Expertise in HPLC, GC, IC, dissolution, and impurity quantification methods
  • Experience developing and executing impurity control strategies
  • Knowledge of ICH stability program design and regulatory expectations
  • Demonstrated GMP documentation and regulatory submission experience

What you'll be doing

  • Develop and validate analytical methods for drug substance and product characterization
  • Design and oversee ICH stability programs for commercial readiness
  • Manage day-to-day analytical activities with CDMOs and contract laboratories
  • Prepare and review GMP documentation, analytical data, and regulatory submissions
  • Investigate out-of-specification results and support nonconformance resolution

Privacy & handoff

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Date posted4 days ago
Last source check1 day ago
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