Head of Science & Regulatory Advanced Cell Models Remote, US
Job Location:
Ashland, OH - USA
Monthly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
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 ACMs 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
- Masters 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 Businesswomens 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 & Womens 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.
Please view equal employment opportunity posters provided by OFCCP here.
Sartorius 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.
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 a specific opening. You can request reasonable accommodation by e-mail at
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 or 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 a specific opening. You can request reasonable accommodation by e-mail at
About Sartorius
Sartorius 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.
Experience:
Director
About Company
Sartorius offers solutions for the biopharmaceutical industry and laboratories, from drug discovery and development to production platforms for biomanufacturing.
