Senior Director, Analytical Sciences

Key Responsibilities:

• 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.

External Partner and Regulatory Support:

• 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.

Qualifications:

• 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.

Compensation & Benefits:

• 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.