Head of Science & Regulatory Advanced Cell Models - US

Sartorius; United States; Híbrido; USD 210.000 - 320.000; Tempo integral

Benefícios oferecidos por esta vaga

401(k) with company match

Health insurance

Professional development

Flexible work arrangements

Resumo da vaga

Sartorius seeks a Head of Science & Regulatory Advanced Cell Models to lead scientific credibility and regulatory acceptance for ACM solutions in the US. This remote role guides validation, external collaboration, and regulatory strategy to accelerate adoption in pharmaceutical applications.

Position requires senior leadership, regulatory insight, and a track record in GLP/GxP environments, with strong KOL networks and strategic influence on product development and portfolio decisions.

Qualificações

• Master’s degree in Life Sciences, Biotechnology, Pharmacology, Toxicology, Regulatory Science, or related field.
• 15+ years in scientific affairs, regulatory science or related areas in life sciences or pharma.
• Experience defining validation strategies and regulatory qualification for complex technologies.

Responsabilidades

• Define scientific validation and regulatory qualification strategies with cross-functional teams.
• Establish evidence frameworks and endpoints to increase customer confidence in ACM.
• Lead regulatory engagement including FDA ISTAND Pilot and DDT pathways; liaise with NIH/NCATS, ICCVAM, NICEATM.
• Build collaborations with KOLs, academia, and regulatory-science initiatives.
• Oversee study design, validation assay development, and application development for ACM.

Conhecimentos

Scientific leadership

Regulatory science

GLP/GxP experience

KOL networks

External collaboration

Formação

Master’s degree in Life Sciences or related field

Descrição da vaga

## Head of Science & Regulatory Advanced Cell Models - USApply: Home Office United States of America: Full time: Posted Yesterday: R41632At 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**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**As a growing global life science company, with our stock listed on the German DAX and TecDAX , Sartorius offers a wide range of benefits: **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 ServiceSartorius 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.Please view equal employment opportunity posters provided by OFCCP here.E-Verify Participation InfoE-Verify Workers RightsSartorius is part of the solution in the fight against cancer, dementia, and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster, so that new therapeutics can reach patients worldwide. We look for ambitious team players and creative minds, who want to contribute to this goal and advance their careers in a dynamic global environment. Join our global team and become part of the solution. We are looking forward to receiving your application.We look forward to receiving your application.