Senior Director, Analytical Sciences; Fully Remote

• Set and lead the analytical direction across the portfolio, ensuring risk-based, phase-appropriate strategies.
• Own analytical method development, validation, transfer, and lifecycle management for drug substance and drug product.
• Provide technical leadership for OOS/OOT investigations, deviations, CAPAs, and complex troubleshooting.

• Lead the external analytical network including CDMOs, CROs, and contract testing laboratories.
• Author, review, and approve analytical content for global regulatory submissions and support inspections.
• Ensure external partners operate in accordance with cGMP requirements and quality agreements.

• Ph.D in Analytical Chemistry, Chemistry, Pharmaceutical Sciences, or related discipline; M.S. with substantial experience considered.
• Typically 15+ years in pharmaceutical/biotech industry with leadership in analytical development.
• Deep expertise in analytical methods, specifications, stability, and impurity control for small molecules.
• US Salary Range: $215,000-$240,000.
• Eligible for standard Company benefits including medical, dental, vision, time off, and 401K.
• May participate in Mineralys incentive plans based on performance.

Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease and obstructive sleep apnea. The company is headquartered in Radnor, Pennsylvania and operates as a fully remote company.