Senior Director, Analytical Sciences

Mineralys Therapeutics · Remote

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Role summary

Mineralys Therapeutics seeks a Senior Director of Analytical Sciences to lead analytical development and regulatory strategy for small molecule drug candidates across all development stages. This remote role requires strategic oversight of analytical methods, specifications, stability programs, external laboratories, and CMC compliance for a clinical-stage biopharmaceutical company.

What they're looking for

Ph.D. in Analytical Chemistry, Chemistry, Pharmaceutical Sciences, or related discipline; M.S. with substantial relevant experience considered
15+ years pharmaceutical or biotechnology industry experience in analytical development or sciences
Progressive leadership experience in analytical development with regulatory submission expertise
Knowledge of analytical method development, validation, and lifecycle management for drug substances and products
Experience managing external partners including CDMOs, CROs, and contract laboratories
Familiarity with cGMP requirements, quality agreements, and health authority interactions

What you'll be doing

Set analytical strategy and direction for drug substance and product portfolio across development phases
Lead method development, qualification, validation, and specification setting for small molecule candidates
Oversee external analytical network including vendor selection, governance, and technical deliverable review
Author and support analytical content for regulatory submissions and respond to health authority questions
Drive cross-functional collaboration with manufacturing, quality, and regulatory teams on CMC plans

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