科学与监管先进细胞模型主管 - 远程，美国
Head of Science & Regulatory Advanced Cell Models - Remote, US
在Sartorius，我们加速创新疗法的开发和生产，为更多人带来更好的健康。作为科学与监管先进细胞模型负责人，您将帮助塑造先进细胞模型（ACM）解决方案的科学可信度、监管认可度和应用开发，以用于制药领域。在这个位于美国的远程职位中，您将领导一个不断壮大的团队，推动科学验证、监管参与和外部合作，以支持可持续的业务增长和创新。
与我们一同成长 – 您的职责
- 通过协调科学、监管和外部利益相关方的活动，制定科学验证和监管资格策略，加快ACM解决方案的采用
- 通过优先考虑验证需求、终点指标和证明阈值，建立科学证据框架，提高客户对ACM技术的信心
- 推动美国的资格认证和监管接受活动，包括FDA ISTAND试点计划和DDT资格路径，并与NIH/NCATS、ICCVAM和NICEATM就新方法的验证进行合作
- 与关键意见领袖、学术机构和监管科学项目建立科学合作，加强ACM的外部科学可信度
- 领导科学实验设计、应用开发和验证实验开发，为ACM应用生成差异化证据
- 评估新兴的科学和监管趋势、外部发展及资格要求，影响未来ACM创新重点
- 将科学证据和验证数据转化为客户相关的见解，支持ACM解决方案的采用和扩展
打动我们的条件
- 生命科学、生物技术、药理学、毒理学、监管科学或相关领域的硕士学位
- 在生命科学、生物技术或制药行业从事科学事务、监管科学、验证或应用开发工作15年以上
- 在受监管环境（如GLP、GxP或ISO）中，具有定义复杂生命科学技术的科学证据、验证和监管资格策略的实际经验
- 对先进细胞模型、NAMs、药物毒理学检测、安全测试和药物发现应用有深入理解
- 在通过KOL网络建立科学可信度方面有成功记录
查看英文原文
At Sartorius, we accelerate the development and production of innovative therapies for better health for more people. As Head of Science & Regulatory Advanced Cell Models, you will help shape scientific credibility, regulatory acceptance, and application development of Advanced Cell Models solutions for pharmaceutical applications. In this remote U.S.-based role, you will lead a growing team and drive scientific validation, regulatory engagement, and external collaboration to support sustainable business growth and innovation.Grow with us – Your Responsibilities
- Define scientific validation and regulatory qualification strategies by coordinating scientific, regulatory, and external stakeholder activities to accelerate adoption of ACM solutions
- Establish scientific evidence frameworks by prioritizing validation requirements, endpoints, and proof thresholds to increase customer confidence in ACM technologies
- Drive U.S. qualification and regulatory acceptance activities, including FDA ISTAND Pilot Program and DDT qualification pathways, and engage with NIH/NCATS, ICCVAM, and NICEATM on the validation of new approach methodologies
- Build scientific collaborations with key opinion leaders, academic institutions, and regulatory-science initiatives to strengthen ACM’s external scientific credibility
- Lead scientific study design, application development, and validation assay development to generate differentiated evidence for ACM applications
- Assess emerging scientific and regulatory trends, external developments, and qualification requirements to influence future ACM innovation priorities
- Translate scientific evidence and validation data into customer-relevant insights to support adoption and expansion of ACM solutions
What will convince us
- Master’s degree in Life Sciences, Biotechnology, Pharmacology, Toxicology, Regulatory Science, or a related field
- 15+ years of experience in scientific affairs, regulatory science, validation, or application development within the life sciences, biotechnology, or pharmaceutical industries
- Demonstrated experience defining scientific evidence, validation, and regulatory qualification strategies for complex life science technologies in regulated environments such as GLP, GxP, or ISO
- Strong understanding of advanced cell models, NAMs, pharmaceutical toxicology assays, safety testing, and drug discovery applications
- Proven track record of building scientific credibility through KOL networks, publications, validation consortia, regulatory-science initiatives, or external scientific collaborations
- Demonstrated ability to influence product, development, portfolio, and commercial decisions through scientific evidence and regulatory insights
- Alignment with our core values: Sustainability, Openness, and Enjoyment
- Ability and willingness to travel domestically and internationally, including monthly visits to the Ashland, MA office
What We Offer
As a growing global life science company, with our stock listed on the German DAX and TecDAX , Sartorius offers a wide range of benefits:
Personal and Professional Development: Mentoring, leadership programs, internal seminar offerings
Worklife Balance: Paid vacation, sick time, corporate holidays and community service day; as well as flexible work schedules
Making an Impact Right from the Start: Comprehensive onboarding, including a virtual online platform
Welcoming Culture: Mutual support, team spirit and international collaboration; communities on numerous topics such as “Coaching”, “Agile Working” and a “Businesswomen’s Network”
Health & Well Being: Wide selection of health and well-being support such as a variety of medical plans to choose from, dental, vision, EAP, and other wellness programs.
Intelligent Working Environment: Working in smart buildings with the latest technology and equipment.
Retirement Savings Plan: 401 k (with generous company match)
Flexible Spending: HSA, FSA (dependent care & healthcare spending), Transportation Commuter Account
Company Paid Benefits: Basic Life Insurance, AD&D, EAP, Family Planning & Women’s Health, Health Advocate
Additional/Optional: Supplemental Life Insurance (employee, spouse & dependents), Legal Services, LTD & STD, Critical Illness Insurance, Student Loan Tuition Refinance Service
Sartorius is an equal opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, national origin, age, protected veteran status, disability or based on status in any other protected group of class.
Please view equal employment opportunity posters provided by OFCCP here.
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Sartorius is part of the solution in the fight against cancer, dementia, and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster, so that new therapeutics can reach patients worldwide. We look for ambitious team players and creative minds, who want to contribute to this goal and advance their careers in a dynamic global environment. Join our global team and become part of the solution. We are looking forward to receiving your application.
We look forward to receiving your application.
If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website, you may request a reasonable accommodation to express interest in a specific opening. You can request reasonable accommodation by e-mail at
Sartorius is an equal opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, national origin, age, protected veteran status, or disability, or based on status in any other protected group of class.
If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website, you may request a reasonable accommodation to express interest in a specific opening. You can request reasonable accommodation by e-mail at
About Sartorius
Sartorius is part of the solution in the fight against cancer, dementia, and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster, so that new therapeutics can reach patients worldwide.
We look for ambitious team players and creative minds, who want to contribute to this goal and advance their careers in a dynamic global environment.
Join our global team and become part of the solution. We are looking forward to receiving your application.
Originally posted on Himalayas