分析科学 高级总监
Senior Director, Analytical Sciences
Mineralys Therapeutics 是一家处于临床阶段的生物制药公司，专注于开发针对高血压及其相关合并症（如慢性肾病（CKD）、阻塞性睡眠呼吸暂停（OSA）和其他由醛固酮失调驱动的疾病）的药物。其首个候选药物 lorundrostat 是一种专有、口服、高度选择性的醛固酮合成酶抑制剂。Mineralys 总部位于宾夕法尼亚州Radnor。更多信息，请访问 https://mineralystx.com。在 LinkedIn、Twitter 和 Bluesky 上关注 Mineralys。
Mineralys 是一家完全远程办公的公司。
职位概述
高级分析科学总监为支持公司小分子原料药和制剂产品组合的开发、注册、验证、上市及生命周期管理的分析活动提供战略和技术领导。该职位负责分析开发、方法生命周期管理、规格设定、稳定性计划、监管支持以及对外部分析实验室、合同开发和生产组织（CDMO）和检测合作伙伴的监督。
作为 CMC 领导团队的关键成员，该职位在所有开发和商业化阶段建立并执行符合各阶段要求的分析策略，同时确保与质量、监管、制造、供应和业务目标保持一致。
主要职责
- 分析策略与领导
- 设定并领导整个产品组合的分析方向，确保方法基于风险、符合阶段要求且适用。
- 作为公司分析化学和药品分析方面的专家。
- 制定并执行原料药、制剂、起始物料、杂质和对照品的综合分析策略。
- 分析开发与控制策略
- 负责原料药和制剂的方法开发、确认、验证、转移、验证和生命周期管理。
- 建立规格、杂质控制、表征、对照品和稳定性计划。
- 提供对 OOS/OOT 调查、偏差、CAPA 和复杂分析问题的技术领导。
- 外部合作伙伴与监管支持
- 领导外部分析网络，包括 CDMO、CRO 和合同检测实验室——选择、治理和技术审查
查看英文原文
“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
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