Head of Science & Regulatory Advanced Cell Models - Remote, US
About The Position
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
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
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
Benefits
- Mentoring
- leadership programs
- internal seminar offerings
- Paid vacation
- sick time
- corporate holidays
- community service day
- flexible work schedules
- Comprehensive onboarding, including a virtual online platform
- Mutual support
- team spirit
- international collaboration
- communities on numerous topics such as “Coaching”, “Agile Working” and a “Businesswomen’s Network”
- Wide selection of health and well-being support such as a variety of medical plans to choose from
- dental
- vision
- EAP
- other wellness programs
- Working in smart buildings with the latest technology and equipment
- 401 k (with generous company match)
- HSA
- FSA (dependent care & healthcare spending)
- Transportation Commuter Account
- Basic Life Insurance
- AD&D
- EAP
- Family Planning & Women’s Health
- Health Advocate
- Supplemental Life Insurance (employee, spouse & dependents)
- Legal Services
- LTD & STD
- Critical Illness Insurance
- Student Loan Tuition Refinance Service
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What This Job Offers
Job Type
Full-time
Career Level
Senior
