Senior Process Engineer - Cell Therapy Process Development

FUJIFILM Holdings America Corporation; Madison (WI); On-site; USD 110,000 - 160,000; Full time

Job summary

FUJIFILM Cellular Dynamics seeks a Senior Process Engineer to advance iPSC-derived therapies within the Process Development (PD) team in Madison, WI. This onsite role focuses on process development, scale-up, and lifecycle planning to deliver robust manufacturing processes for diverse programs.

You will lead technical efforts, collaborate with cross-functional teams, and mentor junior staff while ensuring regulatory alignment and client satisfaction throughout project delivery.

Qualifications

• PhD in biosciences or bioengineering with 2+ years experience; MSc with 5+ years; or BSc with 7+ years; strong industry background preferred.
• Experience leading late-stage clinical and commercial process development for biopharmaceutical manufacturing.
• Experience with scalable upstream and/or downstream operations in cell manufacturing.
• Strong GMP/QA regulatory understanding and capability to support technology transfer and PPQ.
• Ability to mentor and manage engineers, communicating clearly with stakeholders.

Responsibilities

• Independently lead process development activities across programs with robust, scalable processes.
• Evaluate technologies to improve process understanding, robustness, and GMP readiness.
• Provide technical leadership for late-stage development including design space and lifecycle planning.
• Maintain compliant documentation: protocols, reports, risk assessments, and process descriptions.
• Collaborate with MSAT, Manufacturing, Quality, Analytical Development, and clients to meet timelines.

Skills

Process development leadership

Late-stage clinical development

Scale-up & tech transfer

GMP/ICH regulatory knowledge

Mentorship / training

Education

PhD in biosciences or bioengineering

Master's degree + 5+ years experience

Bachelor's degree + 7+ years experience

Tools

DOE methods

Job description

FUJIFILM Cellular Dynamics seeks a Senior Process Engineer to advance iPSC-derived therapies within the Process Development (PD) team in Madison, WI. This onsite role focuses on process development, scale-up, and lifecycle planning to deliver robust manufacturing processes for diverse programs.

You will lead technical efforts, collaborate with cross-functional teams, and mentor junior staff while ensuring regulatory alignment and client satisfaction throughout project delivery.