Senior Director, Analytical Sciences (Fully Remote)

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

• 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.
• 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

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.