Senior Analytical Development Scientist - iPSC Method Leadership

FUJIFILM Holdings America Corporation; Madison (WI); On-site; USD 120,000 - 170,000; Full time

Job summary

FUJIFILM Cellular Dynamics in Madison, WI seeks a Senior Analytical Development Scientist to lead method transfer and development for iPSC-derived therapies. You will collaborate with R&D and QC, apply ICH/Q2/Q14 principles, and drive technology transfer while ensuring regulatory standards and high-quality data.

The role emphasizes hands-on leadership, cross-functional collaboration, and robust documentation to enable IND submissions and product development in a fast-paced, onsite environment.

Qualifications

• PhD in a scientific or engineering discipline or related field with ≥3 years of experience; or a Master’s with ≥7 years; or a Bachelor’s with ≥10 years.
• Experience leading method qualification and validation-readiness with ICH Q2/Q14 principles.
• Proven ability to transition methods from development to QC protocol execution.
• Proficiency with analytical methods including flow cytometry, PCR, and ELISA; stem cell culture experience valued.
• Strong written and oral communication, teamwork, and mentoring skills.

Responsibilities

• Lead analytical development activities across programs, applying scientific judgment to achieve objectives.
• Develop, optimize, and transfer analytical methods; lead comparability studies; support technology deployment.
• Provide technical leadership for method qualification and lifecycle strategies; define acceptance criteria and readiness.
• Ensure regulatory compliance with ICH, USP, ISO, FDA; manage risk assessments for technology transfer.
• Mentor junior staff; train teams; lead small- to mid-sized projects; document all work thoroughly.

Skills

Technical leadership

Cross-functional collaboration

Regulatory knowledge

Written and oral communication

Mentorship

Problem solving / multi-tasking

Education

PhD in science or engineering

MS in science or engineering

BS in science or engineering

Tools

Flow cytometry

PCR

ELISA

Job description

FUJIFILM Cellular Dynamics in Madison, WI seeks a Senior Analytical Development Scientist to lead method transfer and development for iPSC-derived therapies. You will collaborate with R&D and QC, apply ICH/Q2/Q14 principles, and drive technology transfer while ensuring regulatory standards and high-quality data.

The role emphasizes hands-on leadership, cross-functional collaboration, and robust documentation to enable IND submissions and product development in a fast-paced, onsite environment.