"Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor. Mineralys is headquartered in Radnor, Pennsylvania. For more information, please visit https://mineralystx.com. Follow Mineralys on LinkedIn, Twitter and Bluesky"
Mineralys is a fully remote company.
Position Summary
The Senior Director, Analytical Sciences provides strategic and technical leadership for analytical activities supporting the development, registration, validation, launch, and lifecycle management of the company''s small molecule drug substance and drug product portfolio. The role is accountable for analytical development, method lifecycle management, specification setting, stability programs, regulatory support, and oversight of external analytical laboratories, contract development and manufacturing organizations (CDMOs), and testing partners.
As a key member of the CMC leadership team, this individual establishes and executes phase-appropriate analytical strategies across all stages of development and commercialization while ensuring alignment with quality, regulatory, manufacturing, supply, and business objectives.
Key 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.
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.
Preferred Experience
- 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.
Travel
- This position requires up to 10% travel. Frequently travel is outside the local area and overnight.
This position is eligible for standard Company benefits including medical, dental, vision, time off and 401K, as well as participating in Mineralys incentive plans are contingent on achievement of personal and company performance. Actual compensation may vary from posted hiring range based on geographic location, work experience, education, and/or skill level.
US Salary Range: $215,000-$240,000
#LI-Remote