Senior Scientist, iPSC & Advanced Cellular Models R&D

Key Responsibilities & Essential Functions

• Define scientific strategy, technical roadmaps, development priorities, and experimental approaches for assigned iPSC and advanced cellular-model programs.
• Design, plan, direct, and execute complex studies involving iPSC culture, reprogramming, differentiation, characterization, organoids, assembloids, microphysiological systems, and other New Approach Methodology models.
• Evaluate established and emerging internal and external technologies and recommend whether promising capabilities should be developed internally, partnered, licensed, or acquired.
• Lead feasibility, optimization, verification, validation, and translational studies, including definition of technical risks, decision criteria, experimental strategy, and evidence-based go or no-go recommendations.
• Translate early-stage research methods into robust, reproducible, scalable, cost-conscious, production- and automation-ready workflows.
• Establish product and process requirements, critical quality attributes, critical process parameters, acceptance criteria, in-process controls, data requirements, and evidence packages needed for development and technology transfer.
• Analyze and interpret complex experimental, process, and quality data using appropriate statistical and analytical methods; resolve ambiguous technical issues and recommend clear program decisions.
• Troubleshoot complex challenges in iPSC culture, reprogramming, differentiation, characterization, and automated cellular workflows using deep hands-on scientific expertise.
• Provide scientific leadership across multidisciplinary programs involving cell biology, automation, software, quality, operations, project management, product management, and external collaborators.
• Develop and review technical feasibility assessments, development plans, validation strategies, technical reports, publications, presentations, SOPs, and technology-transfer packages.
• Lead or oversee technology transfer to operations teams and help confirm that workflows are reproducible, sufficiently documented, appropriately controlled, and ready for routine execution.
• Mentor and provide technical direction to scientists, associate scientists, technologists, and cross-functional colleagues; supervisory responsibility may be assigned based on business need.
• Communicate technical recommendations, risks, tradeoffs, resource requirements, and program decisions clearly to scientific, operational, commercial, and leadership stakeholders.
• Support stage-gate reviews, resource planning, budget stewardship, continuous improvement, intellectual-property assessment, and commercial enablement for assigned programs.

Knowledge, Skills & Abilities

• Deep, hands-on expertise in human iPSC biology and advanced cellular models, including experience with iPSC expansion, cryopreservation and recovery, maintenance of pluripotency and genomic integrity, reprogramming, directed differentiation, 3D culture, organoids, assembloids, co-culture systems, or related NAM platforms.
• Demonstrated success leading complex scientific programs from concept and feasibility through development, validation, and technology transfer.
• Strong experimental-design, data-interpretation, structured-troubleshooting, risk-assessment, and evidence-based decision-making skills.
• Demonstrated ability to translate research methods into standardized, scalable workflows with defined critical parameters, controls, acceptance criteria, quality attributes, and reproducibility expectations.
• Strong understanding of laboratory automation, liquid handling, high-throughput cell culture, imaging, digital data capture, and the translation of biological requirements for engineering and software partners.
• Proficiency with relevant characterization and analytical methods, which may include flow cytometry, immunocytochemistry, microscopy, molecular assays, viability and functional assays, multi-omics, and statistical analysis.
• Experience with technical transfer, validation or qualification, SOP development, document control, change control, deviation investigation, risk management, or quality systems in a biotechnology, pharmaceutical, production, core-facility, or contract-research environment.
• Demonstrated scientific leadership, mentorship, stakeholder influence, and management of multiple concurrent technical workstreams.
• Strong written and verbal communication skills, including preparation and review of technical reports, presentations, publications, scientific proof points, and recommendations for leadership.
• Ability to evaluate external technologies and collaborators, build productive scientific partnerships, and recommend development, licensing, partnership, or acquisition paths.
• Demonstrated commitment to laboratory safety, data integrity, reproducibility, customer value, continuous improvement, and responsible stewardship of resources.

Education & Experience

Required Education: Master’s degree in stem cell biology, cell biology, developmental biology, bioengineering, biomedical sciences, or a closely related field. Preferred Education: Doctorate in a relevant field. Education Equivalency: In lieu of a master’s degree, a bachelor’s degree in a relevant field plus three additional years of relevant experience will be considered in addition to the experience listed below. Experience Required: 6 years of relevant experience. Experience Preferred: 8 years of relevant experience. Supervisory Experience: The role may include supervisory responsibility based on business need.