Head of Science & Regulatory Advanced Cell Models

## Head of Science & Regulatory Advanced Cell Models - USApply:
Home Office United States of America:
Full time:
Posted Yesterday:
R41632

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”  
**…