商业制造 高级总监
Senior Director, Commercial Manufacturing
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。关注 Mineralys 的 LinkedIn、Twitter 和 Bluesky。
Mineralys 是一家完全远程办公的公司。
职位概述
高级商业制造总监将负责为商业药物产品和 API 的制造活动提供技术及组织领导力、项目管理和监督，以支持扩大生产、验证、上市以及商业产品和样品的持续供应，满足商业部门的需求。
主要职责
- 领导商业制造职能。
- 按时按预算生产药物产品和 API，以满足预测的销售量。
- 参与 Mineralys 销售与运营计划团队，审查实际销售/样品分发情况，并据此修订药物产品和 API 的预测。
- 根据合同要求，向所有 CMO 提供预测更新。
- 从所有 CMO 收集月度生产和库存报告，并提交给 Mineralys 财务部用于月度结账。
- 制定并监督跨项目组合的商业制造策略和运营计划，确保它们与其它职能及公司的战略和运营目标一致。
- 参与商业制造第三方供应商的选择和资质审核。
- 在 100% 外包的业务模式下，监督第三方服务提供商的商业制造运营。
- 准备全球监管文件的支持性文档，并为应对卫生当局的评论和询问提供技术支持，以支持商业营销申请。
- 作为药物产品制造领域的专家（SME），与药物物质、药物产品和分析开发职能密切合作，并在 CMC 团队中代表商业制造职能。
- 与质量保证和法规事务部门合作，确保合规性。
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 Commercial Manufacturing will be responsible for providing technical and organizational leadership, project management and oversight of commercial drug product and API manufacturing activities at all contract manufacturers to support scale-up, validation, launch, and continued supply of commercial products and samples needed by the commercial organization.
Key Responsibilities
- Head the Commercial Manufacturing function.
- Manufactures drug products and API on-time and on-budget to meet forecasted sales volumes.
- Participates on the Mineralys Sales and Operations Planning Team to review actual sales/sample distribution and revises drug product and API forecasts accordingly.
- Provides forecast updates to all CMOs in accordance with contract requirements.
- Provides monthly production and inventory reports from all CMOs to Mineralys Finance for monthly close.
- Establishes and oversees commercial manufacturing strategies and operational plans across a portfolio of projects and ensures that they are aligned with the strategic and operational objectives of other functions, and of the company.
- Participates in the selection and qualification of third-party suppliers for commercial manufacturing.
- Oversees commercial manufacturing operations at third party service providers in a 100% outsourced business model.
- Prepares supporting documentation for global regulatory filings and provides technical support for responses to Health Authority comments and inquiries to support commercial marketing applications.
- As a subject matter expert (SME) in Drug Product Manufacturing, be a key partner to the Drug Substance, Drug Product, and Analytical Development functions and represent the Commercial Manufacturing function on the CMC Team.
- Collaborate with Quality Assurance and Regulatory Affairs to assure compliance with applicable GxP and global regulatory requirements.
- Ensure budget, schedules, and performance requirements are met.
- May hire, mentor, and develop staff according to the future needs of a growing company.
Education & Experience
• Advanced degree in pharmaceutical sciences, engineering, or related discipline. PhD highly preferred.
• A minimum of 15 years’ industry experience in cGMP drug product manufacturing, specifically in the development and manufacturing of small molecule dosage forms; NDA experience required.
• Ideal candidate will also have a minimum of 10 years’ industry experience in manufacturing small molecule API according to cGMP regulations.
• Strong knowledge of US and EU cGMP requirements, ICH guidelines and best practices relating to drug products and API.
• Strong knowledge of formulation development and drug product manufacture across all phases of drug development from initial regulatory filings through registration, scale-up, validation, launch, and commercial supply.
Travel
- This position requires up to 50% 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: $180,000-$200,000
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