Head of Science & Regulatory Advanced Cell Models - US
Sartorius
Summary
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.
Job description
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
Requirements
- 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
Benefits
- Paid vacation
- Sick time
- Corporate holidays
- Community service day
- Flexible work schedules
- Medical plans
- Dental
- Vision
- EAP
- Wellness programs
- 401(k) Matching
- HSA
- FSA
- Transportation commuter account
- Basic life insurance
- AD&D
- Family planning
- Women's health
- Health advocate
- Supplemental life insurance
- Legal services
- LTD
- STD
- Critical illness insurance
- Student loan tuition refinance service
Company overview
Sartorius AG is a leading international partner for life sciences research and the biopharmaceutical industry, headquartered in Göttingen, Germany. Founded in 1870, the company operates through two main divisions: Lab Products & Services and Bioprocess Solutions. The Lab Products & Services division provides innovative laboratory instruments, consumables, and bioanalytics solutions for pharmaceutical, biopharmaceutical, and academic research laboratories, holding market leadership positions in laboratory balances, pipettes, and lab consumables. The Bioprocess Solutions division offers a comprehensive portfolio of single-use technologies covering all steps in biopharmaceutical production, including filtration, fermentation, cell cultivation, and fluid management systems. With over 13,500 employees across more than 60 locations worldwide, Sartorius generated approximately €3.4 billion in sales revenue in 2024. The company serves pharmaceutical and biotechnology companies, academic research facilities, and quality control laboratories, helping accelerate drug discovery and manufacturing processes while maintaining a strong focus on innovation through strategic acquisitions of complementary technologies.