Head of Science & Regulatory Advanced Cell Models

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.

• 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.

• 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.

• 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:…