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

About the role

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 in Advanced Cell Models (ACM) solutions for pharmaceutical applications.

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, new approach methodologies (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 Sartorius core values: Sustainability, Openness, and Enjoyment
• Ability and willingness to travel domestically and internationally, including monthly visits to the Ashland, MA office

Benefits

• Personal and Professional Development: Mentoring, leadership programs, internal seminar offerings
• Worklife Balance: Paid vacation, sick time, corporate holidays, community service day, and flexible work schedules
• Making an Impact Right from the Start: Comprehensive onboarding, including a virtual online platform
• Welcoming Culture: Mutual support, team spirit, international collaboration, and communities on topics such as “Coaching,” “Agile Working,” and a “Businesswomen’s Network”
• Health & Well Being: Wide selection of health and well-being support, including various medical plans, 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: HSA, FSA (dependent care & healthcare spending), Transportation Commuter Account
• Company Paid Benefits: Basic Life Insurance, AD&D, EAP, Family Planning & Women’s Health, Health Advocate
• Additional/Optional Benefits: Supplemental Life Insurance (employee, spouse & dependents), Legal Services, LTD & STD, Critical Illness Insurance, Student Loan Tuition Refinance Service