Head of Science & Regulatory Advanced Cell Models - US

Sartorius; Ashland (MA); Remote; USD 180,000 - 260,000; Full time

Benefits offered by this job

Mentoring & leadership programs

Flexible work schedules

401(k) match

Health & wellbeing programs

Job summary

Sartorius, a leader in scientific solutions, seeks a Head of Science & Regulatory Advanced Cell Models to guide validation, regulatory engagement, and external collaboration for ACM applications in pharma. This remote U.S.-based role leads a growing team and shapes scientific credibility and regulatory acceptance to support growth and innovation.

The role requires deep expertise in NAMs, toxicology, and regulatory science, with travel across domestic and international sites to advance ACM

Qualifications

• 15+ years of experience in scientific affairs, regulatory science, validation, or application development within life sciences or pharma.
• Demonstrated ability to define scientific evidence and regulatory qualification strategies for complex technologies.
• Strong understanding of advanced cell models, NAMs, and toxicology applications.

Responsibilities

• Define scientific validation and regulatory qualification strategies with stakeholders.
• Establish evidence frameworks by prioritizing validation requirements and endpoints.
• Lead U.S. qualification and regulatory activities, engaging with NIH/NCATS, ICCVAM, NICEATM.
• Build collaborations with KOLs, academia, and regulatory-science initiatives.
• Lead study design, application development, and validation assay development.
• Assess trends and qualification requirements to steer innovation priorities.
• Translate evidence into customer insights to support adoption of ACM solutions.

Skills

Leadership experience

Regulatory science

Strategic thinking

KOL networks

Regulatory strategy

Education

Master's degree in Life Sciences

Job description

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.

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

• 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".


• Health & Well Being: Wide selection of health and well-being support such as a variety of medical plans to choose from, 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: Supplemental Life Insurance (employee, spouse & dependents), Legal Services, LTD & STD, Critical Illness Insurance, Student Loan Tuition Refinance Service.

Sartorius is an equal opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, national origin, age, protected veteran status, disability or based on status in any other protected group of class.

If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website, you may request a reasonable accommodation to express interest in this opening. You can request reasonable accommodation by e-mail at [e-mail].