{"id":1537648,"url":"https://alion.io/job/mineralystx-senior-director-analytical-sciences","title":"Senior Director, Analytical Sciences","company":{"id":5577,"name":"Mineralys Therapeutics","domain":"mineralystx.com","url":"https://alion.io/company/mineralystx","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":{"grade":"A","score":95,"open_postings":22,"ghost_share":0,"stale_share":0,"repost_share":0,"time_to_fill_p50_days":69,"computed_at":"2026-10-19T05:45:15Z"}},"role":"Early Careers","role_family":"Early Careers","seniority":"head","employment_type":null,"work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"posting_text","remote_working_hours":null,"hiring_geo_confidence":"structured","locations":[],"countries":[],"hiring_countries":["US"],"hiring_countries_total":1,"salary":{"min":215000,"max":240000,"currency":"USD","period":"year","gross":null,"usd_annual":240000},"salary_estimate":null,"experience_years_min":15,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-09-30T17:25:01Z","employer_posted_date":"2026-09-30","last_verified_at":"2026-10-19T22:01:11Z","board_verified":true,"closed_at":null,"days_open":19,"trust":{"level":"ok","repost_count":0,"flags":[],"days_open":18},"description":"“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”\nMineralys is a fully remote company.\nPosition Summary\nThe 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.\nAs 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.\nKey Responsibilities\nAnalytical Strategy and Leadership\nSet and lead the analytical direction across the portfolio, ensuring approaches are risk-based, phase-appropriate, and fit for purpose.\nServe as the company subject matter expert for analytical chemistry and pharmaceutical analysis.\nDevelop and execute integrated analytical strategies for drug substance, drug product, raw materials, impurities, and reference standards.\nAnalytical Development and Control Strategy\nOwn method development, qualification, validation, transfer, verification, and lifecycle management for drug substance and drug product.\nEstablish specifications, impurity control, characterization, reference standards, and stability programs.\nProvide technical leadership for OOS/OOT investigations, deviations, CAPAs, and complex analytical troubleshooting.\nExternal Partner and Regulatory Support\nLead the external analytical network, including CDMOs, CROs, and contract testing laboratories - selection, governance, and review of technical deliverables.\nAuthor, review, and approve analytical content for global regulatory submissions and support Health Authority questions, audits, and inspections.\nEnsure external partners operate in accordance with cGMP requirements, quality agreements, and company standards.\nCommercialization and Organizational Leadership\nDrive analytical readiness for process validation, launch, continued process verification, and post-approval changes.\nPartner cross-functionally with Drug Substance, Drug Product, Quality, Regulatory, Supply Chain, and Program Management to deliver integrated CMC plans.\nManage budgets, timelines, resources, and technical risk across programs; build and mentor the team as the organization grows.\n\nQualifications\nPh.D in Analytical Chemistry, Chemistry, Pharmaceutical Sciences, or a related scientific discipline; an M.S. with substantial directly relevant experience may be considered.\nTypically 15 or more years of relevant pharmaceutical or biotechnology industry experience, including progressively responsible leadership in analytical development or analytical sciences.\nDemonstrated experience supporting small molecule products from development through regulatory submission, approval, launch, and commercial lifecycle management.\nDeep expertise in analytical method development, validation, transfer, stability, specifications, and impurity control for drug substance and drug product.\nStrong working knowledge of cGMP requirements, ICH guidelines, compendial expectations, data integrity principles, and global CMC regulatory requirements.\nProven ability to lead external analytical partners and manage budgets, timelines, and technical risks across multiple programs.\nExcellent written, verbal, and executive-level communication skills.\nPreferred Experience\nExperience in a virtual, externally networked, or substantially outsourced pharmaceutical operating model.\nExperience with oral solid dosage forms, late-stage development, process validation, and commercial launch readiness.\nExperience building an Analytical Sciences function and establishing scalable governance and operating processes.\nTravel\nThis position requires up to 10% travel. Frequently travel is outside the local area and overnight.\nThis 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.\nUS Salary Range: $215,000-$240,000","description_format":"text","description_chars":5106,"description_truncated":false,"requirements":{"experience_years_min":15,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"phd","optional":false},"security_clearance":false,"languages":[]},"benefits":["401k plan"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Prescription Drugs","Cardiometabolic Therapeutics"],"lifecycle":[{"event":"open","at":"2026-09-30T19:30:36Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":18,"expected_fill_days":69,"reasons":["conf:3","win:early"],"computed_at":"2026-10-19T05:45:15Z"},"pay":{"stated_usd_annual":240000,"is_top_pay":true},"html_url":"https://alion.io/job/mineralystx-senior-director-analytical-sciences","json_url":"https://alion.io/job/mineralystx-senior-director-analytical-sciences.json","meta":{"generated_at":"2026-10-20T00:54:41Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":1253,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-21T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":5577},"rest":"https://alion.io/mcp/rest/get_company?id=5577"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fmineralystx-senior-director-analytical-sciences"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fmineralystx-senior-director-analytical-sciences"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fmineralystx-senior-director-analytical-sciences"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/mineralystx-senior-director-analytical-sciences\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fmineralystx-senior-director-analytical-sciences"}]}