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Head of Science & Regulatory, Advanced Cell Models
SartoriusHead of Science & Regulatory advancing Sartorius’ advanced cell models for pharmaceutical applications. Leading validation, regulatory acceptance, collaborations, and application development.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in scientific validation and regulatory qualification strategies, with a strong focus on advanced cell models and regulatory compliance in life sciences. Proven ability to lead teams and influence product development through scientific evidence and collaboration with key stakeholders.
Highest-signal resume keywords
Scientific Validation StrategiesRegulatory QualificationAdvanced Cell ModelsScientific Study DesignRegulatory Science
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Scientific Evidence FrameworksValidation RequirementsApplication DevelopmentValidation Assay DevelopmentPharmaceutical Toxicology AssaysSafety TestingDrug Discovery ApplicationsRegulated EnvironmentsGLPGxP
Soft Skills
Influencing DecisionsBuilding Scientific CredibilityCollaborationLeadership
Tools & Technologies
FDA ISTAND Pilot ProgramDDT Qualification PathwaysNIH/NCATSICCVAMNICEATM
Industry Keywords
Life SciencesBiotechnologyPharmaceuticalRegulatory ScienceKOL NetworksValidation ConsortiaExternal Scientific Collaborations
About the role
Key responsibilities & impact- Define scientific validation and regulatory qualification strategies by coordinating scientific, regulatory, and external stakeholder activities
- Establish scientific evidence frameworks by prioritizing validation requirements, endpoints, and proof thresholds
- Drive U.S. qualification and regulatory acceptance activities, including FDA ISTAND Pilot Program and DDT qualification pathways
- Engage with NIH/NCATS, ICCVAM, and NICEATM on validation of new approach methodologies
- Build scientific collaborations with key opinion leaders, academic institutions, and regulatory-science initiatives
- Lead scientific study design, application development, and validation assay development
- Assess emerging scientific and regulatory trends, external developments, and qualification requirements
- Influence future Advanced Cell Models innovation priorities
- Translate scientific evidence and validation data into customer-relevant insights to support adoption and expansion of Advanced Cell Models solutions
- Lead a growing team
Requirements
What you’ll need- 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
- 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
- Track record of building scientific credibility through KOL networks, publications, validation consortia, regulatory-science initiatives, or external scientific collaborations
- Ability to influence product, development, portfolio, and commercial decisions through scientific evidence and regulatory insights
- Alignment with Sustainability, Openness, and Enjoyment core values
- Ability and willingness to travel domestically and internationally, including monthly visits to the Ashland, MA office
Benefits
Comp & perks- Mentoring, leadership programs, and internal seminar offerings
- Paid vacation, sick time, corporate holidays, and community service day
- Flexible work schedules
- Comprehensive onboarding, including a virtual online platform
- Mutual support, team spirit, and international collaboration
- Communities on topics such as Coaching, Agile Working, and a Businesswomen’s Network
- Medical, dental, and vision plans
- Employee Assistance Program (EAP)
- Wellness programs
- Smart buildings with the latest technology and equipment
- 401(k) with generous company match
- Health Savings Account (HSA)
- Flexible Spending Accounts (FSA) for dependent care and healthcare spending
- Transportation Commuter Account
- Company-paid basic life insurance
- Company-paid AD&D
- Company-paid family planning and women’s health benefits
- Company-paid Health Advocate
- Optional supplemental life insurance for employee, spouse, and dependents
- Legal services
- Long-term disability (LTD) and short-term disability (STD) insurance
- Critical illness insurance
- Student loan tuition refinance service