Senior Director, Analytical Sciences
Mineralys Therapeutics
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.
Responsibilities
- 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
Requirements
- 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
Vacancy posted 6 days ago
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