Senior Bioprocess Engineer - iPSC Cell Therapy Dev

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

Job summary

FUJIFILM Cellular Dynamics in Madison, WI is seeking a Senior Process Engineer to lead late-stage process development activities within the Process Development team.

You will collaborate with cross-functional teams to design, characterize, scale, and transfer robust cell therapy manufacturing processes for iPSC-derived products, ensuring GMP readiness and regulatory alignment. This onsite role requires strong technical leadership and hands-on experimentation.

Qualifications

• PhD or Master’s with relevant industry experience in biosciences or bioengineering.
• Experience leading late-stage clinical and commercial process development for biopharma.
• Strong understanding of QbD, process validation, and GMP requirements.
• Ability to mentor engineers and collaborate across MSAT, Manufacturing, Quality.

Responsibilities

• Independently plan and lead process development for multiple programs.
• Evaluate technologies to improve robustness, scalability, and GMP readiness.
• Provide technical leadership for characterization, scale-up, and lifecycle planning.
• Communicate strategies and results to internal and external stakeholders.
• Mentor junior engineers and manage small to mid-sized projects.
• Develop and maintain compliant technical documentation.

Skills

Process development

Leadership

Regulatory knowledge

Data analysis

Mentor/mentee

Education

PhD in biosciences or bioengineering

MS in related field

Bachelors in related field

Tools

Cell culture equipment

Bioreactors

Process characterization tools

Job description

FUJIFILM Cellular Dynamics in Madison, WI is seeking a Senior Process Engineer to lead late-stage process development activities within the Process Development team.

You will collaborate with cross-functional teams to design, characterize, scale, and transfer robust cell therapy manufacturing processes for iPSC-derived products, ensuring GMP readiness and regulatory alignment. This onsite role requires strong technical leadership and hands-on experimentation.