Head of Science & Regulatory Advanced Cell Models - Remote, US

Sartorius•Ashland, MA

6d•Remote

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.

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