Senior Analytical Development Scientist

Position Overview

FCDI is seeking a Senior Analytical Development Scientist to support the company’s continued growth and several ongoing projects within the Analytical Development (AD) team located in Madison, Wisconsin.

The AD team works cross-functionally to design, develop, optimize, qualify, and validate analytical methods used to characterize and release a diverse portfolio of induced pluripotent stem cell (iPSC)-derived cell therapy products for ocular, oncological, neurological, and other diseases.

We are seeking an experienced, self-motivated, and detail-oriented scientist who can serve as a technical authority within the analytical development team for method transfer and development in preparation for qualification and validation. In this hands-on laboratory role, you will collaborate closely with Analytical Development leadership, method validation and senior technical staff to ensure that methods are adequately prepared for technology transfer into QC.

This will be achieved by collaborating with the organization's subject matter experts on analytical methods and validation strategies that are scientifically sound, phase-appropriate, compliant with regulatory expectations, and executed consistently.

The successful candidate will be motivated by the opportunity to plan, execute, and lead impactful work to help advance life-changing iPSC-derived therapies from development towards patient administration and enable FCDI to deliver these therapies efficiently, safely, and with the highest standards of quality. This is an onsite role located at our sites in the Madison, WI area.

At FUJIFILM Cellular Dynamics, we’re unlocking the power of human cells to change lives. Using revolutionary induced pluripotent stem cell (iPSC) technology, we drive advancements in drug discovery, disease modeling, cell therapy, research tools, and cell therapy manufacturing. Our mission is deeply meaningful, and we’re looking for bold innovators to join us.

At FUJIFILM Cellular Dynamics, you’ll thrive in a collaborative and cutting-edge environment that encourages creativity and celebrates breakthroughs. If you’re ready to do work that makes a real impact and propels healthcare forward, this is your chance to be part of something extraordinary for science, patients, and yourself.

Our headquarters is in Madison, Wisconsin, a dynamic city celebrated for its lakes, parks, cultural richness, biotech leadership, and access to world-class academia.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit:

Essential Job Functions

• Independently conceive, plan, and lead analytical development activities for multiple internal and external programs, applying advanced scientific judgment to achieve project objectives and generate high-quality results.
• Develop, optimize, and transfer analytical methods across internal teams and external clients. Lead comparability studies to support method, process, or product changes. Partner closely with R&D and technical teams to support the deployment of new technologies and innovative development approaches
• Provide technical leadership and subject matter expertise for analytical method qualification and lifecycle strategies, including protocol development, establishment of acceptance criteria, execution, and definition of readiness criteria for qualification and formal method validation.
• Apply expert knowledge of relevant method guidance such as, but not limited to, ICH, USP, ISO and FDA to ensure analytical methods are scientifically sound, robust, fit for purpose, and compliant with regulatory expectations.
• Lead analytical gap assessments and risk evaluations to identify, prioritize, and proactively address technical and regulatory gaps in support of technology transfer, IND submission, project advancement, and product development objectives. Serve as a subject matter expert during technology transfer and analytical development activities.
• Analyze and interpret complex…