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Salary: USD 215,000 - 240,000 / annual
Mineralys Therapeutics is a clinical-stage biopharmaceutical company developing medicines to treat hypertension and related comorbidities including chronic kidney disease, obstructive sleep apnea, and aldosterone-driven diseases. The company's lead candidate, lorundrostat, is a proprietary oral aldosterone synthase inhibitor.
The Senior Director, Analytical Sciences will provide strategic and technical leadership for all analytical activities supporting development, registration, validation, launch, and lifecycle management of the small molecule drug substance and drug product portfolio. This is a fully remote role reporting into the CMC leadership team.
Key responsibilities include:
• Setting and leading analytical direction across the portfolio with risk-based, phase-appropriate strategies; serving as the company's subject matter expert in analytical chemistry and pharmaceutical analysis.
• Owning method development, qualification, validation, transfer, and lifecycle management for drug substance and drug product; establishing specifications, impurity control, characterization, reference standards, and stability programs.
• Providing technical leadership for out-of-specification/out-of-trend investigations, deviations, corrective and preventive actions, and complex analytical troubleshooting.
• Leading the external analytical network including CDMOs, CROs, and contract testing laboratories through selection, governance, and technical review; ensuring compliance with cGMP requirements and quality agreements.
• Authoring, reviewing, and approving analytical content for global regulatory submissions; supporting Health Authority questions, audits, and inspections.
• Driving analytical readiness for process validation, launch, continued process verification, and post-approval changes.
• Partnering cross-functionally with Drug Substance, Drug Product, Quality, Regulatory, Supply Chain, and Program Management teams to deliver integrated CMC plans.
• Managing budgets, timelines, resources, and technical risk; building and mentoring the team as the organization grows.
Up to 10% travel required, frequently outside the local area and overnight.
QUALIFICATIONS:
• Ph.D. in Analytical Chemistry, Chemistry, Pharmaceutical Sciences, or related scientific discipline; M.S. with substantial directly relevant experience may be considered.
• Typically 15+ 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.
PREFERRED EXPERIENCE:
• Experience in virtual, externally networked, or substantially outsourced pharmaceutical operating models.
• 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.
