Remote Senior Director, Analytical Sciences

Mineralys Therapeutics, Inc.; United States; Remote; USD 215,000 - 240,000; Full time

Benefits offered by this job

Benefits package

Incentive plans

Job summary

Mineralys Therapeutics is seeking a senior leader to direct analytics for a clinical-stage portfolio. You will own method development, validation and lifecycle management for drug substances and products, while guiding investigations and CAPAs.

The role includes managing external partners, ensuring cGMP alignment, and supporting global regulatory submissions and inspections. A PhD with extensive experience is preferred.

Qualifications

• PhD in Analytical Chemistry or related field; MS with substantial experience considered.
• Typically 15+ years in pharma/biotech with leadership in analytical development.
• Deep expertise in analytical methods, specifications, stability and impurity control.

Responsibilities

• Set and lead the analytical direction across the portfolio with risk-based strategies.
• Own analytical method development, validation, transfer, and lifecycle management.
• Provide technical leadership for OOS/OOT investigations, deviations, CAPAs and troubleshooting.
• Lead external analytical network (CDMOs, CROs) and regulatory submissions.

Skills

Analytical method development

Leadership

Regulatory submissions

Education

PhD in Analytical Chemistry

MS in analytical-related field

Tools

cGMP knowledge

Job description

Mineralys Therapeutics is seeking a senior leader to direct analytics for a clinical-stage portfolio. You will own method development, validation and lifecycle management for drug substances and products, while guiding investigations and CAPAs.

The role includes managing external partners, ensuring cGMP alignment, and supporting global regulatory submissions and inspections. A PhD with extensive experience is preferred.