Senior Director, Analytical Sciences

The role

The Senior Director, Analytical Sciences provides strategic and technical leadership for analytical activities supporting the small molecule drug substance and drug product portfolio. This role manages analytical development, method lifecycle, stability programs, and oversight of external partners.

What you will do

• Set and lead the analytical direction across the portfolio
• 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
• Own method development, qualification, validation, transfer, verification, and lifecycle management
• Establish specifications, impurity control, characterization, reference standards, and stability programs
• Provide technical leadership for OOS/OOT investigations, deviations, CAPAs, and complex analytical troubleshooting
• Lead the external analytical network including CDMOs, CROs, and contract testing laboratories
• Author, review, and approve analytical content for global regulatory submissions
• Drive analytical readiness for process validation, launch, continued process verification, and post-approval changes
• Manage budgets, timelines, resources, and technical risk across programs

Required qualifications

• Ph.D in Analytical Chemistry, Chemistry, Pharmaceutical Sciences, or a related scientific discipline; or an M.S. with substantial directly relevant experience
• 15 or more years of relevant pharmaceutical or biotechnology industry experience
• Progressively responsible leadership in analytical development or analytical sciences
• 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

Nice to have

• Experience in a virtual, externally networked, or substantially outsourced pharmaceutical operating model
• Experience with oral solid dosage forms, late-stage development, process validation, and commercial launch readiness
• Experience building an Analytical Sciences function and establishing scalable governance and operating processes

Benefits

• medical
• dental
• vision
• time off
• 401K
• participating in Mineralys incentive plans contingent on achievement of personal and company performance

About the company

Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities. It is headquartered in Radnor, Pennsylvania.