Remote Senior Director, Analytical Sciences

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

Job summary

Mineralys Therapeutics, Inc. is seeking a Senior Director of Analytical Sciences to lead analytical development, method lifecycle management, and specifications for our small molecule drug portfolio.

You will oversee external laboratories, CDMOs, and regulatory support to ensure regulatory readiness and lifecycle management across development and commercialization phases. The role reports to the CMC leadership team and requires strategic vision, strong collaboration with cross-functional teams,

Qualifications

• Ph.D in Analytical Chemistry, Chemistry, Pharmaceutical Sciences, or a related scientific discipline; an M.S. with substantial directly relevant experience may be considered.
• Typically 15 or more years of relevant pharmaceutical or biotechnology industry experience, including progressively responsible leadership in analytical development or analytical sciences.
• Demonstrated experience supporting small molecule products from development through regulatory submission, approval, launch, and commercial lifecycle management.
• Deep expertise in analytical method development, validation, transfer, stability, specifications, and impurity control for drug substance and drug product.
• Strong working knowledge of cGMP requirements, ICH guidelines, compendial expectations, data integrity principles, and global CMC regulatory requirements.
• Proven ability to lead external analytical partners and manage budgets, timelines, and technical risks across multiple programs.
• Excellent written, verbal, and executive-level communication skills.

Responsibilities

• Analytical Strategy and Leadership: Set and lead the analytical direction across the portfolio, ensuring approaches are risk-based, phase-appropriate, and fit for purpose.
• Serve as the company subject matter expert for analytical chemistry and pharmaceutical analysis.
• Develop and execute integrated analytical strategies for drug substance, drug product, raw materials, impurities, and reference standards.
• Analytical Development and Control Strategy: Own method development, qualification, validation, transfer, verification, and lifecycle management for drug substance and drug product.
• Establish specifications, impurity control, characterization, reference standards, and stability programs.
• Provide technical leadership for OOS/OOT investigations, deviations, CAPAs, and complex analytical troubleshooting.
• External Partner and Regulatory Support: Lead the external analytical network, including CDMOs, CROs, and contract testing laboratories - selection, governance, and review of technical deliverables.
• Author, review, and approve analytical content for global regulatory submissions and support Health Authority questions, audits, and inspections.
• Ensure external partners operate in accordance with cGMP requirements, quality agreements, and company standards.
• Commercialization and Organizational Leadership: Drive analytical readiness for process validation, launch, continued process verification, and post-approval changes.
• Partner cross-functionally with Drug Substance, Drug Product, Quality, Regulatory, Supply Chain, and Program Management to deliver integrated CMC plans.
• Manage budgets, timelines, resources, and technical risk across programs; build and mentor the team as the organization grows.

Education

Ph.D in Analytical Chemistry

M.S. with substantial directly relevant experience

Job description

Mineralys Therapeutics, Inc. is seeking a Senior Director of Analytical Sciences to lead analytical development, method lifecycle management, and specifications for our small molecule drug portfolio.

You will oversee external laboratories, CDMOs, and regulatory support to ensure regulatory readiness and lifecycle management across development and commercialization phases. The role reports to the CMC leadership team and requires strategic vision, strong collaboration with cross-functional teams,